AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC: 72508-203
11-digit product format: 725080203
Labeler code: 72508
Product ID: 72508-203_256c881f-2ff6-4af4-876c-fc860860e3a6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Neopharma Inc
Application: NDA050755
Marketing category: NDA
Marketing start: 2020-02-18
Marketing end: 2022-06-01
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: 0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	72508-203		D	Discontinued by firm	2026-10-05
excluded package	package	72508-203	72508-203-51	D	Discontinued by firm	2026-10-05
excluded package	package	72508-203	72508-203-54	D	Discontinued by firm	2026-10-05
excluded package	package	72508-203	72508-203-69	D	Discontinued by firm	2026-10-05

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 · 48 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 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72508-203-51	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72508-203-69	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72508-203-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72508-203-51	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72508-203-69	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72508-203-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72508-203-51	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72508-203-69	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72508-203-54	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72508-203-51	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72508-203-69	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72508-203-54	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72508-203-51	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72508-203-69	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72508-203-54	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72508-203-51	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72508-203-69	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72508-203-54	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72508-203-51	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72508-203-69	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72508-203-54	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72508-203-51	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72508-203-69	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72508-203-54	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72508-203-51	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72508-203-69	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72508-203-54	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72508-203-51	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72508-203-69	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72508-203-54	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	72508-203-51	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	72508-203-69	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	72508-203-54	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	72508-203-51	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	72508-203-69	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	72508-203-54	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N050755-001	AUGMENTIN ES-600	AMOXICILLIN; CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050755-001	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL		RLD	2001-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL		RLD	2001-06-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL		RLD	2001-06-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL		RLD	2001-06-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050755-001	AUGMENTIN ES-600	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	2001-06-22	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N050755-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050755-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050755-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050755-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050755-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050755-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050755-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050755-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050755-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050755-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050755-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050755-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050755-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050755-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050755-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050755-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050755-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050755-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050755-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N050755-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050755-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050755-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050755-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050755-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050755-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050755-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050755-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050755-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050755-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050755-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050755-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050755-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050755-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050755-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050755-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050755-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050755-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050755-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050755-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
72508-203-51	2021-08-09	These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium 600mg/42.9mg per 5 mL Powder for Oral Suspension, USP safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium 600mg/42.9mg per 5 mL Powder for Oral Suspension, USP. Amoxicillin and Clavulanate Potassium 600mg/42.9mg per 5 mL Powder for Oral Suspension, USP Initial U.S. Approval: 2001 To reduce the development of drug-resistant bacteria and maintain the effectiven
72508-203-54	2021-08-09	These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium 600mg/42.9mg per 5 mL Powder for Oral Suspension, USP safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium 600mg/42.9mg per 5 mL Powder for Oral Suspension, USP. Amoxicillin and Clavulanate Potassium 600mg/42.9mg per 5 mL Powder for Oral Suspension, USP Initial U.S. Approval: 2001 To reduce the development of drug-resistant bacteria and maintain the effectiven
72508-203-69	2021-08-09	These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium 600mg/42.9mg per 5 mL Powder for Oral Suspension, USP safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium 600mg/42.9mg per 5 mL Powder for Oral Suspension, USP. Amoxicillin and Clavulanate Potassium 600mg/42.9mg per 5 mL Powder for Oral Suspension, USP Initial U.S. Approval: 2001 To reduce the development of drug-resistant bacteria and maintain the effectiven
72508-203-51	2021-07-23	These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium 600mg/42.9mg per 5 mL Powder for Oral Suspension, USP safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium 600mg/42.9mg per 5 mL Powder for Oral Suspension, USP. Amoxicillin and Clavulanate Potassium 600mg/42.9mg per 5 mL Powder for Oral Suspension, USP Initial U.S. Approval: 2001 To reduce the development of drug-resistant bacteria and maintain the effectiven
72508-203-54	2021-07-23	These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium 600mg/42.9mg per 5 mL Powder for Oral Suspension, USP safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium 600mg/42.9mg per 5 mL Powder for Oral Suspension, USP. Amoxicillin and Clavulanate Potassium 600mg/42.9mg per 5 mL Powder for Oral Suspension, USP Initial U.S. Approval: 2001 To reduce the development of drug-resistant bacteria and maintain the effectiven
72508-203-69	2021-07-23	These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium 600mg/42.9mg per 5 mL Powder for Oral Suspension, USP safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium 600mg/42.9mg per 5 mL Powder for Oral Suspension, USP. Amoxicillin and Clavulanate Potassium 600mg/42.9mg per 5 mL Powder for Oral Suspension, USP Initial U.S. Approval: 2001 To reduce the development of drug-resistant bacteria and maintain the effectiven

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72508-203-51	ML - Milliliter	72508-203	15c9522d-981b-4624-a4fa-92f381fec90c	1	2020-09-14
72508-203-54	ML - Milliliter	72508-203	86ae9561-39b1-49fa-8542-6a9fdfb9c963	1	2020-09-14
72508-203-69	ML - Milliliter	72508-203	8ec5ba64-0798-4e6d-b3a2-032fc19937e0	1	2020-09-14

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 · 4 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	USAntibiotics, LLC	7d4dfd6f-bd1a-4acc-8506-07fca08f8a38	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050755 application number: NDA050755
AUGMENTIN ES-600	AMOXICILLIN AND CLAVULANATE POTASSIUM	USAntibiotics, LLC	59979859-8c9b-4173-a5e3-2e6312fd9d79	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050755 application number: NDA050755
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Redpharm Drug	2fbb57ba-08d8-0224-e063-6294a90ab683	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050755 application number: NDA050755
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals, Inc.	2bb03d3b-5d44-bc4a-e063-6394a90a656a	2025-01-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050755 application number: NDA050755

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72508-203-51	72508020351	75 mL in 1 BOTTLE (72508-203-51)	75 ml	2020-02-18	2022-06-01	No	No	Current
72508-203-54	72508020354	200 mL in 1 BOTTLE (72508-203-54)	200 ml	2020-02-18	2022-06-01	No	No	Current
72508-203-69	72508020369	125 mL in 1 BOTTLE (72508-203-69)	125 ml	2020-02-18	2022-06-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMOXICILLIN AND CLAVULANATE POTASSIUM	Neopharma Inc \| USAntibiotics, LLC	2021-08-09	Human Prescription Drug Label	2