Amoxicillin and Clavulanate Potassium

Product NDC: 50090-4413
11-digit product format: 500904413
Labeler code: 50090
Product ID: 50090-4413_048fe5ef-29fa-49ac-a63e-00d2b1a7aa1e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA091568
Marketing category: ANDA
Marketing start: 2012-01-20
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: 2026-12-31
Current FDA listing: Yes

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
A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB		2012-01-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091568-001	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	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091568-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2012-01-20	`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	A091568-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091568-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091568-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091568-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091568-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091568-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091568-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091568-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091568-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091568-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091568-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091568-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091568-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091568-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091568-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091568-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091568-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091568-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091568-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091568-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091568-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091568-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091568-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091568-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091568-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091568-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091568-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091568-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091568-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091568-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091568-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091568-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091568-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091568-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091568-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091568-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091568-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091568-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091568-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091568-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Amoxicillin and Clavulanate Potassium
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
804826J2HU	Internal UNII lookup
Q42OMW3AT8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
562508	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
aaa35f65-cb9c-4b37-a126-c5ff2c2ef79d	Available on FDA.report

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
50090-4413-0	2024-02-15	C162847	48780-1	f386c649-b502-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS 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
50090-4413-0	2023-01-30	C162847	48780-1	f386c649-b502-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-4413-0	Amoxicillin and Clavulanate Potassium	20 in 1 BOTTLE	TABLET, FILM COATED	20	9
50090-4413-0	Amoxicillin and Clavulanate Potassium	48 in 1 CASE	TABLET, FILM COATED	48	9
50090-4413-1	Amoxicillin and Clavulanate Potassium	24 in 1 CASE	TABLET, FILM COATED	24	9
50090-4413-1	Amoxicillin and Clavulanate Potassium	20 in 1 BOTTLE	TABLET, FILM COATED	20	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4413-0	EA - Each	50090-4413	1fa9430c-b09b-47d1-96a7-55eae001c872	1	2024-03-12
50090-4413-1	EA - Each	50090-4413	9aa60b0b-009e-4aec-88e7-b96e3722dfd8	1	2024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4413	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	9	Current NDC, Legacy NDC, 4 package rows	20240517_aaa35f65-cb9c-4b37-a126-c5ff2c2ef79d.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 2 · 30 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.	77b82fac-3f6e-44c9-8dcc-362f01ad7a4b	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceutials,Inc.	e0902485-69f0-7351-e053-2a95a90aa0d0	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Northwind Health Company, LLC	26e1d503-ab8b-ca85-e063-6394a90aaae3	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals, Inc.	535d2b1e-cd74-0ede-e063-6394a90ac06f	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	263a2902-f85c-46b6-8d5b-8c99f5c4b706	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Coupler LLC	5102cf09-9c52-ede4-e063-6394a90abd46	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Sportpharm LLC	fabeca32-3f26-4b65-b8b6-5f0e23765ab0	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	REMEDYREPACK INC.	80bef3fd-4f6f-4190-8865-9ac46c8947a3	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	a1d6bf78-4bb7-469e-ba39-318e14aaee29	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	7ef8592d-c7d0-49a4-a559-3190e559fa2f	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	dfdde253-44b8-4074-b759-7bc40ea26cf9	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	American Health Packaging	4966a3f2-eed2-4081-ba88-310a3d1964b4	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Sportpharm LLC	94b7c1bb-c024-4dc6-86d4-18a17a3eafcb	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	776da91b-0626-1090-e053-2a91aa0a40f0	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	REMEDYREPACK INC.	704e99b1-c14a-40bf-adbd-c2794fa92c72	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	924a9ef6-5e3d-4e78-ae97-ae090f6613c0	2025-09-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NorthStar Rx LLC	d75b0a7e-cb9b-4102-bcac-097403b25129	2025-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	80be54ec-2a38-4125-a1a8-e58f50800dd2	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Bryant Ranch Prepack	f8bfb851-3000-4523-8584-4e9c679a9765	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Aurobindo Pharma Limited	ffb158a1-83ba-4100-9221-175aa986dc3e	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091568 application number: ANDA091568

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	aaa35f65-cb9c-4b37-a126-c5ff2c2ef79d	9
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	aaa35f65-cb9c-4b37-a126-c5ff2c2ef79d	9
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	aaa35f65-cb9c-4b37-a126-c5ff2c2ef79d	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4413-0	50090441300	48 BOTTLE in 1 CASE (50090-4413-0) / 20 TABLET, FILM COATED in 1 BOTTLE	48 bottle	2019-07-16	0000-00-00	No	No	Current
50090-4413-1	50090441301	24 BOTTLE in 1 CASE (50090-4413-1) / 20 TABLET, FILM COATED in 1 BOTTLE	24 bottle	2024-02-14		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium	A-S Medication Solutions	2024-05-16	Human Prescription Drug Label	9