Amoxicillin and Clavulanate Potassium

Product NDC: 69452-336
11-digit product format: 694520336
Labeler code: 69452
Product ID: 69452-336_3d370466-2b90-4d0b-9bf8-6297353d18ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA065064
Marketing category: ANDA
Marketing start: 2022-08-01
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: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69452-336		D	Discontinued by firm		2026-08-11
excluded package	package	69452-336	69452-336-11	D	Discontinued by firm		2026-08-11

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB		2002-03-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065064-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065064-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	500MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-03-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065064-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065064-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065064-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065064-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065064-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065064-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065064-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065064-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065064-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065064-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065064-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065064-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065064-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065064-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065064-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065064-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065064-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065064-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065064-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065064-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065064-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065064-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065064-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065064-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065064-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065064-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065064-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065064-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065064-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065064-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065064-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065064-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065064-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065064-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065064-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065064-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065064-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065064-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065064-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065064-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69452-336-11	EA - Each	69452-336	58633202-c153-46ec-87ba-9125ff854821	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-336	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [BIONPHARMA INC.]	5	Legacy NDC	20240514_80daca9e-1539-4f25-911f-b8868438ced8.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 · 7 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	Bryant Ranch Prepack	22cd4e96-2288-470c-9264-8058cd7db9b0	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065064 application number: ANDA065064
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	f748b118-6d50-487a-824d-1c92ab2028c0	2025-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065064 application number: ANDA065064
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Sandoz Inc	7cba82f0-9886-46e9-8dbd-43a448aade29	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065064 application number: ANDA065064
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN AND CLAVULANATE POTASSIUM	DirectRx	cdc6d30a-754e-6672-e053-2a95a90afa7f	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065064 application number: ANDA065064
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Asclemed USA, Inc.	a94cfba3-27ed-46a3-81ef-e9b80187c207	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065064 application number: ANDA065064
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	71812ac4-9264-49f2-b9ab-ea1efd1af452	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065064 application number: ANDA065064
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	01b30abb-db63-4257-9fe2-9107bb0bd69c	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065064 application number: ANDA065064

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
69452-336-11	69452033611	20 TABLET, FILM COATED in 1 BOTTLE (69452-336-11)	2022-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium	Bionpharma Inc. \| Sandoz GmbH	2025-07-02	HUMAN PRESCRIPTION DRUG LABEL	6