Amoxicillin and Clavulanate Potassium

Product NDC: 43063-377
Requested package NDC: 43063-377-02
11-digit product format: 430630377
Labeler code: 43063
Product ID: 43063-377_41379c75-8030-e15f-e063-6394a90a6a3b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA065096
Marketing category: ANDA
Marketing start: 2002-10-31
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
A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB		2002-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065096-001	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	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065096-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	875MG;EQ 125MG BASE	TABLET / ORAL	AB	2002-10-29	`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	A065096-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065096-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065096-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065096-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065096-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065096-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065096-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065096-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065096-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065096-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065096-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065096-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065096-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065096-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065096-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065096-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065096-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065096-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065096-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065096-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065096-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065096-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065096-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065096-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065096-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065096-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065096-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065096-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065096-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065096-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065096-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065096-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065096-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065096-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065096-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065096-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065096-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065096-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065096-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065096-001	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
416fa58c-88fa-42aa-9195-74aeba641577	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43063-377-02	Amoxicillin and Clavulanate Potassium	2 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	2		27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-377-02	EA - Each	43063-377	8c420b3e-068a-48e3-9b12-3fa6d0e8104b	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-377	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	26	Current NDC, Legacy NDC, 1 package rows	20240809_416fa58c-88fa-42aa-9195-74aeba641577.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	Preferred Pharmaceuticals Inc.	1127a41b-14a1-4fe8-ae37-67ea5d760301	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065096 application number: ANDA065096
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	REMEDYREPACK INC.	aa77bab1-1c08-43bf-a943-0399646b3e1c	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065096 application number: ANDA065096
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	e340b67b-332e-4e0c-aebf-ad4872dc5ed4	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065096 application number: ANDA065096
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	b04330a0-2b8d-4cf9-a08e-19007d1001ad	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065096 application number: ANDA065096
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	PD-Rx Pharmaceuticals, Inc.	416fa58c-88fa-42aa-9195-74aeba641577	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065096 application number: ANDA065096 ndc (package): 43063-377-02 ndc (product): 43063-377 ndc11 (package): 43063037702
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Teva Pharmaceuticals USA, Inc.	963e7bea-ff5d-420a-9cb2-e4aefb534b33	2024-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065096 application number: ANDA065096
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Asclemed USA, Inc.	f05a27dd-5ced-4f62-8a0c-548c3a033f5e	2022-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065096 application number: ANDA065096

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	416fa58c-88fa-42aa-9195-74aeba641577	27
562508	amoxicillin 875 MG / clavulanate 125 MG Oral Tablet	SCD	416fa58c-88fa-42aa-9195-74aeba641577	27
562508	amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet	SY	416fa58c-88fa-42aa-9195-74aeba641577	27

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-377-02	43063037702	2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-377-02)	2012-08-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium	PD-Rx Pharmaceuticals, Inc.	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	27