Amoxicillin and Clavulanate Potassium

Product NDC: 68071-2853
11-digit product format: 680712853
Labeler code: 68071
Product ID: 68071-2853_ebca319a-d330-b5bd-e053-2a95a90abeff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA065063
Marketing category: ANDA
Marketing start: 2002-03-14
Marketing end: 0000-00-00
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 875 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	68071-2853		I	Inactivated by FDA		2026-08-03
excluded package	package	68071-2853	68071-2853-2	I	Inactivated by FDA		2026-08-03

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 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	68071-2853		I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2853	68071-2853-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	68071-2853		I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2853	68071-2853-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	68071-2853		I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2853	68071-2853-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	68071-2853		I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2853	68071-2853-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	68071-2853		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2853	68071-2853-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	68071-2853		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2853	68071-2853-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	68071-2853		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2853	68071-2853-2	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	68071-2853		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2853	68071-2853-2	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	68071-2853		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2853	68071-2853-2	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065063-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065063-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2002-03-14	`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	A065063-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065063-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065063-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065063-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065063-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065063-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065063-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065063-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065063-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065063-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065063-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065063-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065063-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065063-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065063-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065063-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065063-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065063-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065063-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065063-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065063-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065063-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065063-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065063-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065063-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065063-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065063-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065063-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065063-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065063-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065063-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065063-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065063-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065063-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065063-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065063-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065063-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065063-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065063-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065063-001	AB	1	`cb3db0bc1861…`

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 · 11 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	REMEDYREPACK INC.	c88b2b50-c664-43b3-9c37-f134a329dc21	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals, Inc.	377abca8-7076-9ad0-e063-6294a90aa5dc	2025-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals, Inc.	348f7f77-ba7e-5dd9-e063-6294a90a0991	2025-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063
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): 065063 application number: ANDA065063
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals, Inc.	31d00820-1c20-d52b-e063-6394a90ac312	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	f9b4d263-bc5b-6065-e053-6394a90a5e35	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063
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): 065063 application number: ANDA065063
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	917a76e9-eb2b-4d49-9418-ff919a73cfad	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	a0d22635-0e11-448d-b151-6f6168c65723	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	5b68b2bf-b581-4372-87be-a6394ee56961	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	f636413f-82e5-446f-94cc-b4841bdedb33	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065063 application number: ANDA065063

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
68071-2853-2	2025-01-30	C162847	48780-1	2cef2736-6db5-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, oral suspension and chewable tablets for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2853-2	Amoxicillin and Clavulanate Potassium	20 in 1 BOTTLE	TABLET, FILM COATED	20		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2853	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20221027_ebca3633-3850-c5fa-e053-2a95a90a37a2.zip

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
562508	amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet	PSN	ebca3633-3850-c5fa-e053-2a95a90a37a2	1
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	ebca3633-3850-c5fa-e053-2a95a90a37a2	1
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	ebca3633-3850-c5fa-e053-2a95a90a37a2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2853-2	68071285302	20 TABLET, FILM COATED in 1 BOTTLE (68071-2853-2)	2022-10-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium	NuCare Pharmaceuticals,Inc.	2022-10-24	HUMAN PRESCRIPTION DRUG LABEL	1