AMOXICILLIN AND CLAVULANATE POTASSIUM

Product NDC: 70518-4758
11-digit product format: 705184758
Labeler code: 70518
Product ID: 70518-4758_5bffe4a4-4117-0b52-e063-6294a90a43ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amoxicillin and clavulanate potassium
Dosage form: TABLET, COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA050720
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2026-09-21
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 875; 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N050720-001	AUGMENTIN '875'	AMOXICILLIN; CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050720-001	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 · 44 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
2026-10-15 13:18:30	2026-09	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050720-001	AUGMENTIN '875'	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RLD	1996-02-13	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N050720-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050720-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050720-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050720-001	AB	1	`a50c72e98297…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMOXICILLIN	875 mg/1
CLAVULANATE POTASSIUM	125 mg/1

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 · 3 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	Preferred Pharmaceuticals Inc.	1b8a6312-ae47-45fb-ba5e-eedbc176afa0	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050720 application number: NDA050720
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	00cf4429-e37c-4490-b22d-3cd796124296	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050720 application number: NDA050720
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	0d40bc70-8f47-48c2-a7c6-ba7db9cace74	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050720 application number: NDA050720

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

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1152875	amoxicillin / clavulanate Pill	amoxicillin / clavulanate Pill	SCDG Active

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4758-0	70518475800	100 POUCH in 1 BOX (70518-4758-0) / 1 TABLET, COATED in 1 POUCH (70518-4758-1)	100 pouch	2026-09-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMOXICILLIN AND CLAVULANATE POTASSIUM	REMEDYREPACK INC.	2026-09-21	HUMAN PRESCRIPTION DRUG LABEL	1