Amoxicillin and Clavulanate Potassium

Product NDC: 65862-503
11-digit product format: 658620503
Labeler code: 65862
Product ID: 65862-503_2b91e9f8-c77e-4330-8fc1-e574758f0db6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA091568
Marketing category: ANDA
Marketing start: 2012-01-20
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 875; 125 mg/1; mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished product	product	65862-503		UNFINISHED	Active or certified unfinished drug listing		2026-08-07
unfinished package	package	65862-503	65862-503-82	UNFINISHED	Active or certified unfinished drug listing		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-503-82	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-503-82	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-503-82	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-503-82	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-503-82	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-503-82	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-503-82	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-503-82	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-503-82	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-503-82	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-503-82	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-503-82	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-503-82	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-503-82	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-503-82	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-503-82	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-503-82	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-503-82	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-503-82	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-503-82	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	65862-503-82	`5b2001dcd8f5…`	`54b53d4dc9e4…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A091568-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091568-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091568-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091568-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091568-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091568-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091568-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091568-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091568-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091568-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091568-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091568-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091568-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091568-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091568-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091568-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091568-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091568-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091568-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091568-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091568-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091568-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091568-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091568-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091568-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091568-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091568-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091568-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091568-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091568-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091568-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091568-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091568-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091568-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091568-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091568-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091568-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091568-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091568-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091568-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091568-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Amoxicillin and Clavulanate Potassium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMOXICILLIN	875 mg/1
CLAVULANATE POTASSIUM	125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
804826J2HU	Internal UNII lookup
Q42OMW3AT8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
562251	Internal RxNorm lookup
562508	Internal RxNorm lookup
617296	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ffb158a1-83ba-4100-9221-175aa986dc3e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
502415e5-4ac7-4266-a01a-ef44aa3c028d	Product name	7	20250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0f	Product name	3	20250620
2ebbc361-d28f-48a9-a286-c1ae09cdaf5c	Product name	3	20230314
2bb254ff-3d7f-4bdb-abf9-476506008c55	Product name	1	20230117
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206
cf3f1c02-1f32-2322-3314-b70ebbf5610e	Product name	1	20140508
ebb3e917-326a-9e18-0354-a19c9f63a2f3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65862-503-01	Amoxicillin and Clavulanate Potassium	100 in 1 BOTTLE	TABLET, FILM COATED	100		23
65862-503-20	Amoxicillin and Clavulanate Potassium	20 in 1 BOTTLE	TABLET, FILM COATED	20		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-503-01	EA - Each	65862-503	e9f771e4-123e-4f4b-9bc9-78bb525faaab	1	2012-07-24
65862-503-20	EA - Each	65862-503	9179cba0-9e32-4072-8ce8-e25ae66ba740	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	4
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	4
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	4
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	4
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	4
HYPROMELLOSE 2910 (15000 MPA.S)	INACTIVE INGREDIENT	288VBX44JC	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	4
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	4
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	4
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	4
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
HYPROMELLOSE 2910 (15000 MPA.S)	INACTIVE INGREDIENT	288VBX44JC	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	3
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECT RX]	2
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECT RX]	2
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECT RX]	2
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECT RX]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECT RX]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECT RX]	2
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECT RX]	2
HYPROMELLOSE 2910 (15000 MPA.S)	INACTIVE INGREDIENT	288VBX44JC	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECT RX]	2
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECT RX]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECT RX]	2
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECT RX]	2
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECT RX]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECT RX]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECT RX]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECT RX]	2
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	1
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]	1
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]	1
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	1
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	1
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]	1
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	1
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
HYPROMELLOSE 2910 (15000 MPA.S)	INACTIVE INGREDIENT	288VBX44JC	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
HYPROMELLOSE 2910 (15000 MPA.S)	INACTIVE INGREDIENT	288VBX44JC	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	1
HYPROMELLOSE 2910 (15000 MPA.S)	INACTIVE INGREDIENT	288VBX44JC	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]	1
HYPROMELLOSE 2910 (15000 MPA.S)	INACTIVE INGREDIENT	288VBX44JC	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	1
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]	1
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECTRX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-503	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	21	Current NDC, Legacy NDC, 2 package rows	20240821_ffb158a1-83ba-4100-9221-175aa986dc3e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	REMEDYREPACK INC.	77b82fac-3f6e-44c9-8dcc-362f01ad7a4b	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceutials,Inc.	e0902485-69f0-7351-e053-2a95a90aa0d0	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Northwind Health Company, LLC	26e1d503-ab8b-ca85-e063-6394a90aaae3	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals, Inc.	535d2b1e-cd74-0ede-e063-6394a90ac06f	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	263a2902-f85c-46b6-8d5b-8c99f5c4b706	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Coupler LLC	5102cf09-9c52-ede4-e063-6394a90abd46	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Sportpharm LLC	fabeca32-3f26-4b65-b8b6-5f0e23765ab0	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	REMEDYREPACK INC.	80bef3fd-4f6f-4190-8865-9ac46c8947a3	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	a1d6bf78-4bb7-469e-ba39-318e14aaee29	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	7ef8592d-c7d0-49a4-a559-3190e559fa2f	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	dfdde253-44b8-4074-b759-7bc40ea26cf9	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	American Health Packaging	4966a3f2-eed2-4081-ba88-310a3d1964b4	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Sportpharm LLC	94b7c1bb-c024-4dc6-86d4-18a17a3eafcb	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	776da91b-0626-1090-e053-2a91aa0a40f0	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	REMEDYREPACK INC.	704e99b1-c14a-40bf-adbd-c2794fa92c72	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	924a9ef6-5e3d-4e78-ae97-ae090f6613c0	2025-09-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NorthStar Rx LLC	d75b0a7e-cb9b-4102-bcac-097403b25129	2025-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	80be54ec-2a38-4125-a1a8-e58f50800dd2	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	f8bfb851-3000-4523-8584-4e9c679a9765	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Aurobindo Pharma Limited	ffb158a1-83ba-4100-9221-175aa986dc3e	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568 ndc (product): 65862-503

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
804826J2HU	AMOXICILLIN	61336-70-7	AMOXICILLIN
Q42OMW3AT8	CLAVULANATE POTASSIUM	61177-45-5	CLAVULANATE POTASSIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
617296	amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet	PSN	af4c2ea8-73bd-429b-8392-fa20fec6fb3f	25
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	af4c2ea8-73bd-429b-8392-fa20fec6fb3f	25
617296	amoxicillin 500 MG / clavulanate 125 MG Oral Tablet	SCD	af4c2ea8-73bd-429b-8392-fa20fec6fb3f	25
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	af4c2ea8-73bd-429b-8392-fa20fec6fb3f	25
617296	amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	af4c2ea8-73bd-429b-8392-fa20fec6fb3f	25
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	af4c2ea8-73bd-429b-8392-fa20fec6fb3f	25
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	a1d6bf78-4bb7-469e-ba39-318e14aaee29	24
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	7ef8592d-c7d0-49a4-a559-3190e559fa2f	24
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	a1d6bf78-4bb7-469e-ba39-318e14aaee29	24
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	7ef8592d-c7d0-49a4-a559-3190e559fa2f	24
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	7ef8592d-c7d0-49a4-a559-3190e559fa2f	24
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	a1d6bf78-4bb7-469e-ba39-318e14aaee29	24
562251	amoxicillin 250 MG / clavulanate potassium 125 MG Oral Tablet	PSN	ffb158a1-83ba-4100-9221-175aa986dc3e	23
617296	amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet	PSN	ffb158a1-83ba-4100-9221-175aa986dc3e	23
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	ffb158a1-83ba-4100-9221-175aa986dc3e	23
562251	amoxicillin 250 MG / clavulanate 125 MG Oral Tablet	SCD	ffb158a1-83ba-4100-9221-175aa986dc3e	23
617296	amoxicillin 500 MG / clavulanate 125 MG Oral Tablet	SCD	ffb158a1-83ba-4100-9221-175aa986dc3e	23
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	ffb158a1-83ba-4100-9221-175aa986dc3e	23
562251	amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	ffb158a1-83ba-4100-9221-175aa986dc3e	23
617296	amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	ffb158a1-83ba-4100-9221-175aa986dc3e	23
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	ffb158a1-83ba-4100-9221-175aa986dc3e	23
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	77b82fac-3f6e-44c9-8dcc-362f01ad7a4b	22
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	77b82fac-3f6e-44c9-8dcc-362f01ad7a4b	22
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	77b82fac-3f6e-44c9-8dcc-362f01ad7a4b	22
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	aaa35f65-cb9c-4b37-a126-c5ff2c2ef79d	9
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	aaa35f65-cb9c-4b37-a126-c5ff2c2ef79d	9
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	aaa35f65-cb9c-4b37-a126-c5ff2c2ef79d	9
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	776da91b-0626-1090-e053-2a91aa0a40f0	8
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	80bef3fd-4f6f-4190-8865-9ac46c8947a3	8
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	776da91b-0626-1090-e053-2a91aa0a40f0	8
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	80bef3fd-4f6f-4190-8865-9ac46c8947a3	8
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	776da91b-0626-1090-e053-2a91aa0a40f0	8
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	80bef3fd-4f6f-4190-8865-9ac46c8947a3	8
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	b6c893e7-3bf3-4d4b-aa65-b35d2d9d8228	6
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	9069433e-10c0-4a5a-a94a-104fe212621e	6
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	b6c893e7-3bf3-4d4b-aa65-b35d2d9d8228	6
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	9069433e-10c0-4a5a-a94a-104fe212621e	6
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	b6c893e7-3bf3-4d4b-aa65-b35d2d9d8228	6
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	9069433e-10c0-4a5a-a94a-104fe212621e	6
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	1728cab8-5c19-4f89-e054-00144ff88e88	5
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	92ff1408-512c-d68d-e053-2a95a90adfbd	5
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	61cfb334-ebad-6290-e053-2a91aa0aea0d	5
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	1728cab8-5c19-4f89-e054-00144ff88e88	5
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	92ff1408-512c-d68d-e053-2a95a90adfbd	5
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	61cfb334-ebad-6290-e053-2a91aa0aea0d	5
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	92ff1408-512c-d68d-e053-2a95a90adfbd	5
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	61cfb334-ebad-6290-e053-2a91aa0aea0d	5
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	1728cab8-5c19-4f89-e054-00144ff88e88	5
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	7870336b-1f49-bcf4-e053-2991aa0af8b7	4
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	7870336b-1f49-bcf4-e053-2991aa0af8b7	4
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	7870336b-1f49-bcf4-e053-2991aa0af8b7	4
617296	amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet	PSN	94b7c1bb-c024-4dc6-86d4-18a17a3eafcb	3
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	1e91c5ce-3482-47ca-92e7-e492196992d9	3
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	f601c634-2271-2fcd-e053-2995a90aaaba	3
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	94b7c1bb-c024-4dc6-86d4-18a17a3eafcb	3
617296	amoxicillin 500 MG / clavulanate 125 MG Oral Tablet	SCD	94b7c1bb-c024-4dc6-86d4-18a17a3eafcb	3
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	1e91c5ce-3482-47ca-92e7-e492196992d9	3
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	f601c634-2271-2fcd-e053-2995a90aaaba	3
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	94b7c1bb-c024-4dc6-86d4-18a17a3eafcb	3
617296	amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	94b7c1bb-c024-4dc6-86d4-18a17a3eafcb	3
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	1e91c5ce-3482-47ca-92e7-e492196992d9	3
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	f601c634-2271-2fcd-e053-2995a90aaaba	3
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	94b7c1bb-c024-4dc6-86d4-18a17a3eafcb	3
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	26e1d503-ab8b-ca85-e063-6394a90aaae3	2
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	1d73e25f-69e5-3845-e054-00144ff8d46c	2
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	f8bfb851-3000-4523-8584-4e9c679a9765	2
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	c57c76d1-5fae-469a-b492-bb192c7bb590	2
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	80be54ec-2a38-4125-a1a8-e58f50800dd2	2
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	26e1d503-ab8b-ca85-e063-6394a90aaae3	2
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	c57c76d1-5fae-469a-b492-bb192c7bb590	2
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	1d73e25f-69e5-3845-e054-00144ff8d46c	2
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	80be54ec-2a38-4125-a1a8-e58f50800dd2	2
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	f8bfb851-3000-4523-8584-4e9c679a9765	2
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	c57c76d1-5fae-469a-b492-bb192c7bb590	2
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	80be54ec-2a38-4125-a1a8-e58f50800dd2	2
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	1d73e25f-69e5-3845-e054-00144ff8d46c	2
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	26e1d503-ab8b-ca85-e063-6394a90aaae3	2
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	f8bfb851-3000-4523-8584-4e9c679a9765	2
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	e0902485-69f0-7351-e053-2a95a90aa0d0	1
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	5102cf09-9c52-ede4-e063-6394a90abd46	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-503-01	65862050301	100 TABLET, FILM COATED in 1 BOTTLE (65862-503-01)	2012-01-20	0000-00-00	No	No	Current
65862-503-20	65862050320	20 TABLET, FILM COATED in 1 BOTTLE (65862-503-20)	2012-01-20	0000-00-00	No	No	Current
65862-503-82	65862050382	800 TABLET, FILM COATED in 1 BAG (65862-503-82)	20-JAN-12				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium	PD-Rx Pharmaceuticals, Inc.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	24
Amoxicillin and Clavulanate Potassium	REMEDYREPACK INC.	2026-07-21	HUMAN PRESCRIPTION DRUG LABEL	23
Amoxicillin and Clavulanate Potassium	NuCare Pharmaceutials,Inc. \| NuCare Pharmaceuticals,Inc.	2026-06-23	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin and Clavulanate Potassium	NuCare Pharmaceuticals,Inc.	2026-06-18	HUMAN PRESCRIPTION DRUG LABEL	6
Amoxicillin and Clavulanate Potassium	Northwind Health Company, LLC	2026-06-18	HUMAN PRESCRIPTION DRUG LABEL	3
Amoxicillin and Clavulanate Potassium	Bryant Ranch Prepack	2026-05-27	HUMAN PRESCRIPTION DRUG LABEL	1
Amoxicillin and Clavulanate Potassium	Coupler LLC	2026-05-04	HUMAN PRESCRIPTION DRUG LABEL	1
Amoxicillin and Clavulanate Potassium	REMEDYREPACK INC.	2026-04-15	HUMAN PRESCRIPTION DRUG LABEL	8
Amoxicillin and Clavulanate Potassium	PD-Rx Pharmaceuticals, Inc.	2026-03-23	HUMAN PRESCRIPTION DRUG LABEL	24
Amoxicillin and Clavulanate Potassium	PD-Rx Pharmaceuticals, Inc.	2026-03-20	HUMAN PRESCRIPTION DRUG LABEL	24
Amoxicillin and Clavulanate Potassium	Bryant Ranch Prepack	2026-03-12	HUMAN PRESCRIPTION DRUG LABEL	1
Amoxicillin and Clavulanate Potassium	Sportpharm LLC	2026-02-04	HUMAN PRESCRIPTION DRUG LABEL	3
Amoxicillin and Clavulanate Potassium	ASCLEMED USA INC.	2026-02-03	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin and Clavulanate Potassium	NuCare Pharmaceuticals,Inc.	2026-01-28	HUMAN PRESCRIPTION DRUG LABEL	8
Amoxicillin and Clavulanate Potassium	Bryant Ranch Prepack	2025-08-19	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin and Clavulanate Potassium	Bryant Ranch Prepack	2025-08-19	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	2025-07-01	Human Prescription Drug Label	23
Amoxicillin and Clavulanate Potassium	A-S Medication Solutions	2025-06-18	Human Prescription Drug Label	25
Amoxicillin and Clavulanate Potassium	A-S Medication Solutions	2025-06-18	Human Prescription Drug Label	6
Amoxicillin and Clavulanate Potassium	Preferred Pharmaceuticals Inc.	2025-02-27	HUMAN PRESCRIPTION DRUG LABEL	1