AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC: 61919-020
11-digit product format: 619190020
Labeler code: 61919
Product ID: 61919-020_f200babf-07c9-d922-e053-2a95a90a2179
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DIRECT RX
Application: ANDA091568
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 875 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: 2024-12-31
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-020		I	Inactivated by FDA	2026-08-07
excluded package	package	61919-020	61919-020-14	I	Inactivated by FDA	2026-08-07
excluded package	package	61919-020	61919-020-20	I	Inactivated by FDA	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 · 29 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-020-20	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-020-14	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-020-20	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-020-14	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-020-20	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-020-14	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-020-20	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-020-14	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-020-20	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-020-14	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-020-20	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-020-14	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-020-14	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-020-20	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-020-14	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-020-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-020-14	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-020-20	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61919-020-20	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-020-14	2025-01-30	C162847	48780-1	2cef2736-8faa-d83d-e063-dadaa90ab31f	AMOXICILLIN AND CLAVULANATE POTASSIUM
61919-020-20	2025-01-30	C162847	48780-1	2cef2736-8faa-d83d-e063-dadaa90ab31f	AMOXICILLIN AND CLAVULANATE POTASSIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-020-14	AMOXICILLIN AND CLAVULANATE POTASSIUM	14 in 1 BOTTLE	TABLET, FILM COATED	14		6
61919-020-20	AMOXICILLIN AND CLAVULANATE POTASSIUM	20 in 1 BOTTLE	TABLET, FILM COATED	20		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-020-14	EA - Each	61919-020	ff1d7713-cfa4-4c28-9d59-54d8bfa706c0	1	2023-09-05
61919-020-20	EA - Each	61919-020	c1085992-d099-4335-a769-a3f7b66a84d1	1	2015-04-03

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 [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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-020	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DIRECT RX]	6	Legacy NDC, 2 package rows	20230808_b6c893e7-3bf3-4d4b-aa65-b35d2d9d8228.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

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
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	b6c893e7-3bf3-4d4b-aa65-b35d2d9d8228	6
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	b6c893e7-3bf3-4d4b-aa65-b35d2d9d8228	6
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	b6c893e7-3bf3-4d4b-aa65-b35d2d9d8228	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-020-14	61919002014	14 in 1 BOTTLE					Historical
61919-020-20	61919002020	20 TABLET, FILM COATED in 1 BOTTLE (61919-020-20)	2015-01-01	0000-00-00	No	No	Current