Amoxicillin and Clavulanate Potassium

Product NDC: 65862-501
Requested package NDC: 65862-501-15
11-digit product format: 658620501
Labeler code: 65862
Product ID: 65862-501_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: ANDA091569
Marketing category: ANDA
Marketing start: 2012-01-20
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 250; 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	65862-501	65862-501-15	UNFINISHED	Active or certified unfinished drug listing		2026-09-14

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 · 21 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20
A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091569-001	AB
A091569-002	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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2012-01-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091569-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091569-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091569-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091569-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091569-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091569-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091569-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091569-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091569-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091569-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091569-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091569-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091569-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091569-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091569-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091569-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091569-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091569-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091569-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091569-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091569-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091569-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091569-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091569-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091569-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091569-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091569-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091569-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091569-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091569-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091569-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091569-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091569-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091569-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091569-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091569-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091569-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091569-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091569-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091569-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091569-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091569-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	250 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
Q42OMW3AT8	Internal UNII lookup
804826J2HU	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
65862-501-05	Amoxicillin and Clavulanate Potassium	500 in 1 BOTTLE	TABLET, FILM COATED	500		23
65862-501-30	Amoxicillin and Clavulanate Potassium	30 in 1 BOTTLE	TABLET, FILM COATED	30		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-501-30	EA - Each	65862-501	9b620431-09b1-4d01-8b4c-36917b905dfd	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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-501	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 1 · 13 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	NuCare Pharmaceuticals,Inc.	92ff1408-512c-d68d-e053-2a95a90adfbd	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569
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): 091569 application number: ANDA091569
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): 091569 application number: ANDA091569
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals Inc.	d23b6952-5e4c-4103-9fe0-a916b1e2e1b9	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569
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): 091569 application number: ANDA091569
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	48356a07-60b9-c844-e063-6394a90afafa	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	f433611c-db72-af7f-e053-2995a90a4a70	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	ef2c7783-e419-288f-e053-2a95a90a628a	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	b509d0eb-fe01-4902-89ae-a0dc7f7c7f93	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569
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): 091569 application number: ANDA091569
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): 091569 application number: ANDA091569 ndc (product): 65862-501
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	af4c2ea8-73bd-429b-8392-fa20fec6fb3f	2025-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	46921419-9fae-4f51-b1b2-dc2e1ab04e8e	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091569 application number: ANDA091569

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
65862-501-15	65862050115	1500 TABLET, FILM COATED in 1 BAG (65862-501-15)	20-JAN-12	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium	Aurobindo Pharma Limited	2026-09-07	Human Prescription Drug Label	24