Amoxicillin and Clavulanate Potassium

Product NDC: 70934-086
Requested package NDC: 70934-086-20
11-digit product format: 709340086
Labeler code: 70934
Product ID: 70934-086_d1f37272-6f1e-5877-e053-2a95a90ae207
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amoxicillin and clavulanate potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application: ANDA065093
Marketing category: ANDA
Marketing start: 2019-10-14
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: 2022-12-31
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	70934-086	70934-086-20	I	Inactivated by FDA		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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB		2002-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065093-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065093-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-11-21	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065093-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065093-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065093-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065093-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065093-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065093-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065093-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065093-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065093-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065093-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065093-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065093-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065093-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065093-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065093-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065093-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065093-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065093-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065093-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065093-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065093-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065093-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065093-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065093-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065093-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065093-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065093-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065093-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065093-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065093-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065093-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065093-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065093-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065093-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065093-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065093-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065093-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065093-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065093-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065093-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
70934-086-20	2023-01-30	C162847	48780-1	f386c64a-2037-0266-e053-dadaa90a7c1a	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 TABLETS. AMOXICILLIN and CLAVULANATE Potassium 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 tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets sho

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70934-086-20	Amoxicillin and Clavulanate Potassium	20 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	20		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70934-086-20	EA - Each	70934-086	bb35a527-8dec-4753-b1d0-a04a7e5a02a3	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70934-086	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]	4	Legacy NDC, 1 package rows	20211230_6cd02b4d-3f42-b84f-e053-2a91aa0a367e.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	6cd02b4d-3f42-b84f-e053-2a91aa0a367e	4
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	6cd02b4d-3f42-b84f-e053-2a91aa0a367e	4
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	6cd02b4d-3f42-b84f-e053-2a91aa0a367e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70934-086-20	70934008620	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-086-20)	2019-10-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-11-29	HUMAN PRESCRIPTION DRUG LABEL	4