Amoxicillin and Clavulanate Potassium

Product NDC: 70882-111
Requested package NDC: 70882-111-20
11-digit product format: 708820111
Labeler code: 70882
Product ID: 70882-111_f0063b1e-af9e-474d-96b9-0b3aa1a37ea2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cambridge Therapeutics Technologies, LLC
Application: ANDA065189
Marketing category: ANDA
Marketing start: 2005-08-23
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 250; 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: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	70882-111	70882-111-20	I	Inactivated by FDA		2026-08-03

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
A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065189-001	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	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065189-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	250MG;EQ 125MG BASE	TABLET / ORAL	AB	RS	2005-08-23	`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	A065189-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065189-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065189-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065189-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065189-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065189-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065189-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065189-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065189-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065189-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065189-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065189-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065189-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065189-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065189-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065189-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065189-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065189-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065189-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065189-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065189-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065189-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065189-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065189-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065189-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065189-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065189-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065189-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065189-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065189-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065189-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065189-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065189-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065189-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065189-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065189-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065189-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065189-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065189-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065189-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 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	Sandoz Inc	7cba82f0-9886-46e9-8dbd-43a448aade29	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065189 application number: ANDA065189
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): 065189 application number: ANDA065189

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70882-111-20	Amoxicillin and Clavulanate Potassium	20 in 1 BLISTER PACK	TABLET, FILM COATED	20		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70882-111-20	EA - Each	70882-111	74982130-6b50-488f-bec0-d093ded4b407	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70882-111	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [CAMBRIDGE THERAPEUTICS TECHNOLOGIES, LLC]	1	Current NDC, Legacy NDC, 1 package rows	20161216_a4c9694c-f539-470e-bfe3-8723fa1c343d.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
562251	amoxicillin 250 MG / clavulanate potassium 125 MG Oral Tablet	PSN	a4c9694c-f539-470e-bfe3-8723fa1c343d	1
562251	amoxicillin 250 MG / clavulanate 125 MG Oral Tablet	SCD	a4c9694c-f539-470e-bfe3-8723fa1c343d	1
562251	amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	a4c9694c-f539-470e-bfe3-8723fa1c343d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70882-111-20	70882011120	20 TABLET, FILM COATED in 1 BLISTER PACK (70882-111-20)	2005-08-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium	Cambridge Therapeutics Technologies, LLC	2016-12-16	HUMAN PRESCRIPTION DRUG LABEL	1