AUGMENTIN

Product NDC: 72508-006
Requested package NDC: 72508-006-14
11-digit product format: 725080006
Labeler code: 72508
Product ID: 72508-006_fff71910-9217-475a-af12-5e4ef4b11a60
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amoxicillin and clavulanate potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Neopharma Inc
Application: NDA050564
Marketing category: NDA
Marketing start: 2019-03-01
Marketing end: 0000-00-00
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 500 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: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	72508-006	72508-006-14	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 · 12 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 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N050564-001	AUGMENTIN '250'	AMOXICILLIN; CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-08-06
N050564-002	AUGMENTIN '500'	AMOXICILLIN; CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1984-08-06

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1984-08-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE	TABLET / ORAL	RLD	1984-08-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE	TABLET / ORAL	RLD	1984-08-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE	TABLET / ORAL	RLD	1984-08-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE	TABLET / ORAL	RLD	1984-08-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050564-001	AUGMENTIN '250'	250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1984-08-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050564-002	AUGMENTIN '500'	500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1984-08-06	`74a2ff9319b5…`

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
72508-006-14	2021-08-10	These highlights do not include all the information needed to use AUGMENTIN safely and effectively. See full prescribing information for AUGMENTIN. AUGMENTIN®(amoxicillin/clavulanate potassium) Tablets, Powder for Oral Suspension, and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN should be used only to treat infections that are proven or strongly suspected to be caused by
72508-006-78	2021-08-10	These highlights do not include all the information needed to use AUGMENTIN safely and effectively. See full prescribing information for AUGMENTIN. AUGMENTIN®(amoxicillin/clavulanate potassium) Tablets, Powder for Oral Suspension, and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN should be used only to treat infections that are proven or strongly suspected to be caused by
72508-006-14	2021-07-23	These highlights do not include all the information needed to use AUGMENTIN safely and effectively. See full prescribing information for AUGMENTIN. AUGMENTIN®(amoxicillin/clavulanate potassium) Tablets, Powder for Oral Suspension, and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN should be used only to treat infections that are proven or strongly suspected to be caused by
72508-006-78	2021-07-23	These highlights do not include all the information needed to use AUGMENTIN safely and effectively. See full prescribing information for AUGMENTIN. AUGMENTIN®(amoxicillin/clavulanate potassium) Tablets, Powder for Oral Suspension, and Chewable Tablets Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN should be used only to treat infections that are proven or strongly suspected to be caused by

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	Marketing start	Marketing end	Sample	Exclude flag	Status
72508-006-14	72508000614	20 TABLET, FILM COATED in 1 BOTTLE (72508-006-14)	2019-03-01	0000-00-00	No	No	Current