Amoxicillin and Clavulanate Potassium

Product NDC: 53002-3716
11-digit product format: 530023716
Labeler code: 53002
Product ID: 53002-3716_c65de933-1491-4d39-931a-35aa827c6336
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA201091
Marketing category: ANDA
Marketing start: 2011-12-20
Marketing end: 0000-00-00
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 600 mg/5mL; mg/5mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	53002-3716		I	Inactivated by FDA	2026-09-14
excluded package	package	53002-3716	53002-3716-1	I	Inactivated by FDA	2026-09-14
excluded package	package	53002-3716	53002-3716-2	I	Inactivated by FDA	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 · 27 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	53002-3716-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-3716-2	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	53002-3716-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-3716-2	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	53002-3716-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-3716-2	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	53002-3716-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-3716-2	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	53002-3716-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-3716-2	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	53002-3716-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-3716-2	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	53002-3716-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-3716-2	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	53002-3716-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-3716-2	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	53002-3716-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-3716-2	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

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
A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2011-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201091-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A201091-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201091-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201091-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201091-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201091-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201091-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201091-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201091-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201091-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201091-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201091-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201091-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201091-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201091-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201091-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201091-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201091-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201091-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201091-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201091-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201091-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201091-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201091-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201091-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201091-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201091-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201091-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201091-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201091-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201091-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201091-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201091-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201091-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201091-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201091-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201091-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201091-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201091-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201091-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201091-001	AB	1	`f41ea6bd6efb…`

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, Related label table
NDC	Effective	Related label
53002-3716-1	2025-01-30	These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION. AMOXICILLIN and CLAVULANATE potassium for oral suspension, for oral use Initial U.S. Approval: 2001
53002-3716-2	2025-01-30	These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION. AMOXICILLIN and CLAVULANATE potassium for oral suspension, for oral use Initial U.S. Approval: 2001
53002-3716-1	2023-06-07	These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION. AMOXICILLIN and CLAVULANATE potassium for oral suspension, for oral use Initial U.S. Approval: 2001
53002-3716-2	2023-06-07	These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION. AMOXICILLIN and CLAVULANATE potassium for oral suspension, for oral use Initial U.S. Approval: 2001
53002-3716-1	2023-01-30	These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION. AMOXICILLIN and CLAVULANATE potassium for oral suspension, for oral use Initial U.S. Approval: 2001
53002-3716-2	2023-01-30	These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION. AMOXICILLIN and CLAVULANATE potassium for oral suspension, for oral use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-3716-1	Amoxicillin and Clavulanate Potassium	200 mL in 1 BOTTLE, PLASTIC	POWDER, FOR SUSPENSION	200		4
53002-3716-2	Amoxicillin and Clavulanate Potassium	75 mL in 1 BOTTLE, PLASTIC	POWDER, FOR SUSPENSION	75		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-3716	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [RPK PHARMACEUTICALS, INC.]	4	Legacy NDC, 2 package rows	20230609_476ea419-8d88-40f0-a329-960e5e3859c6.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 · 12 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	Redpharm Drug	5250085e-5509-c577-e063-6294a90a9b87	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals, Inc.	22a387bd-92ce-4ebc-b475-20d7750a2507	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	bcd19a89-e9dc-b85f-e053-2a95a90a6f3e	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	2a376d67-0bf2-43a1-8ca3-73f90689c339	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	ebf49514-0bce-ac56-e053-2a95a90ae540	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	ccb8bfb1-1303-4c2d-9106-78684e6b859f	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NorthStar Rx LLC	df4136c0-9efd-42c3-a487-e728e8b91275	2025-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Aurobindo Pharma Limited	5200ae31-8a79-45f9-84fc-98f8448483a7	2025-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	9ba5b2b2-3c27-a2a8-e053-2a95a90a97cd	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	a0ff848d-230a-ab6b-e053-2a95a90a8bb8	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	e05caabb-b95c-4e54-890e-bbc371a20fc3	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	bb75eb89-2579-4189-8dd2-40ae8727fe7c	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091

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
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension	PSN	476ea419-8d88-40f0-a329-960e5e3859c6	4
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	476ea419-8d88-40f0-a329-960e5e3859c6	4
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	476ea419-8d88-40f0-a329-960e5e3859c6	4
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	476ea419-8d88-40f0-a329-960e5e3859c6	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-3716-1	53002371601	200 mL in 1 BOTTLE, PLASTIC (53002-3716-1)	200 ml	2021-01-01	0000-00-00	No	No	Current
53002-3716-2	53002371602	75 mL in 1 BOTTLE, PLASTIC (53002-3716-2)	75 ml	2021-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium	RPK Pharmaceuticals, Inc.	2023-06-07	Human Prescription Drug Label	4