AUGMENTIN ES-600

Product NDC: 43598-003
11-digit product format: 435980003
Labeler code: 43598
Product ID: 43598-003_0756200b-9953-58d9-b495-409d3cbf8c1d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amoxicillin and clavulanate potassium
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Dr Reddys Laboratories Inc
Application: NDA050755
Marketing category: NDA
Marketing start: 2012-10-31
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: E
Listing certified through: 2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43598-003		I	Inactivated by FDA	2026-10-05
excluded package	package	43598-003	43598-003-51	I	Inactivated by FDA	2026-10-05
excluded package	package	43598-003	43598-003-54	I	Inactivated by FDA	2026-10-05
excluded package	package	43598-003	43598-003-69	I	Inactivated by FDA	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 2 · 88 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	43598-003-69	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43598-003-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43598-003-51	`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	43598-003-69	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43598-003-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43598-003-51	`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	43598-003-69	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43598-003-54	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43598-003-51	`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	43598-003-69	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43598-003-54	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43598-003-51	`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	43598-003-69	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43598-003-54	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43598-003-51	`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	43598-003-69	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43598-003-54	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43598-003-51	`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	43598-003-69	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43598-003-54	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43598-003-51	`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	43598-003-69	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43598-003-54	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43598-003-51	`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	43598-003-69	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43598-003-54	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43598-003-51	`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	43598-003-69	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43598-003-54	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43598-003-51	`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	43598-003-69	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43598-003-54	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43598-003-51	`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	43598-003-69	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43598-003-54	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43598-003-51	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43598-003-69	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43598-003-54	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43598-003-51	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43598-003-69	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43598-003-54	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43598-003-51	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43598-003-69	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43598-003-54	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43598-003-51	`1332a3947898…`	`d4bfe170f9cd…`

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.

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
43598-003-51	2020-01-31	C162847	48780-1	9d75b9cf-e36f-f424-e053-dadaa90a57ce	AUGMENTIN ES-600 ® Powder for Oral Suspension (amoxicillin/clavulanate potassium)
43598-003-54	2020-01-31	C162847	48780-1	9d75b9cf-e36f-f424-e053-dadaa90a57ce	AUGMENTIN ES-600 ® Powder for Oral Suspension (amoxicillin/clavulanate potassium)
43598-003-69	2020-01-31	C162847	48780-1	9d75b9cf-e36f-f424-e053-dadaa90a57ce	AUGMENTIN ES-600 ® Powder for Oral Suspension (amoxicillin/clavulanate potassium)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43598-003-51	AUGMENTIN ES-600	75 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	75	1
43598-003-54	AUGMENTIN ES-600	200 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	200	1
43598-003-69	AUGMENTIN ES-600	125 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	125	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-003-51	ML - Milliliter	43598-003	1abbfdcc-02da-4967-b1e4-3fd5f23900da	1	2013-02-13
43598-003-54	ML - Milliliter	43598-003	53c0b6eb-9eda-489c-8c70-ee2818fb10df	1	2013-02-13
43598-003-69	ML - Milliliter	43598-003	77a7471e-6f04-4888-8bb8-439aaad0e688	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AUGMENTIN ES-600 (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR REDDYS LABORATORIES INC]	1
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AUGMENTIN ES-600 (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR REDDYS LABORATORIES INC]	1
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AUGMENTIN ES-600 (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR REDDYS LABORATORIES INC]	1
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AUGMENTIN ES-600 (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR REDDYS LABORATORIES INC]	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	AUGMENTIN ES-600 (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR REDDYS LABORATORIES INC]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	AUGMENTIN ES-600 (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR REDDYS LABORATORIES INC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AUGMENTIN ES-600 (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR REDDYS LABORATORIES INC]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AUGMENTIN ES-600 (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR REDDYS LABORATORIES INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-003	AUGMENTIN ES-600 (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [DR REDDYS LABORATORIES INC]	1	Legacy NDC, 3 package rows	20121203_55aefa88-46fc-2b73-0819-0c2f88274852.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 · 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

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	55aefa88-46fc-2b73-0819-0c2f88274852	1
618028	AUGMENTIN ES 600 MG / 42.9 MG in 5 mL Oral Suspension	PSN	55aefa88-46fc-2b73-0819-0c2f88274852	1
618028	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension [Augmentin]	SBD	55aefa88-46fc-2b73-0819-0c2f88274852	1
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	55aefa88-46fc-2b73-0819-0c2f88274852	1
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	55aefa88-46fc-2b73-0819-0c2f88274852	1
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	55aefa88-46fc-2b73-0819-0c2f88274852	1
618028	Augmentin ES 600 MG / 42.9 MG per 5 ML Oral Suspension	SY	55aefa88-46fc-2b73-0819-0c2f88274852	1
618028	Augmentin ES-600 (amoxicillin 600 MG / clavulanate 42.9 MG) per 5 ML Oral Suspension	SY	55aefa88-46fc-2b73-0819-0c2f88274852	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
43598-003-51	43598000351	75 mL in 1 BOTTLE	75 ml	Historical
43598-003-54	43598000354	200 mL in 1 BOTTLE	200 ml	Historical
43598-003-69	43598000369	125 mL in 1 BOTTLE	125 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AUGMENTIN ES-600 ® Powder for Oral Suspension (amoxicillin/clavulanate potassium)	Dr Reddys Laboratories Inc \| Dr. Reddy's Laboratories Inc DBA Dr. Reddy's Laboratories Tennessee LLC \| Beecham Pharmaceuticals (PTE) Limited \| SmithKline Beecham Limited	2012-12-03	HUMAN PRESCRIPTION DRUG LABEL	1