Amoxicillin and Clavulanate Potassium

Product NDC: 81964-220
11-digit product format: 819640220
Labeler code: 81964
Product ID: 81964-220_52498ef2-86fc-72b6-e063-6294a90a4232
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amoxicillin and clavulanate potassium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: USAntibiotics, LLC
Application: NDA050785
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2025-12-15
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM; AMOXICILLIN SODIUM
Active strength: 562.5; 62.5; 437.5 mg/1; mg/1; mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
N050785-001	AUGMENTIN XR	AMOXICILLIN; CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050785-001	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-09-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2002-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2002-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2002-09-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2002-09-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2002-09-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050785-001	AUGMENTIN XR	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-09-25	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N050785-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050785-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050785-001	AB	1	`011fe1cb6892…`
2019-12-13 00:20 UTC	2019-12	N050785-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N050785-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050785-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050785-001	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050785-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050785-001	6746692	2020-04-04		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050785-001	6783773	2020-04-04		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050785-001	6878386	2020-04-04	U-926		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050785-001	7217430	2020-04-04	U-926	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050785-001	7250176	2020-04-04	U-926		`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N050785-001	6746692	2020-04-04		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050785-001	6783773	2020-04-04		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050785-001	6878386	2020-04-04	U-926		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050785-001	7217430	2020-04-04	U-926	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050785-001	7250176	2020-04-04	U-926		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050785-001	6746692	2020-04-04		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050785-001	6783773	2020-04-04		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050785-001	6878386	2020-04-04	U-926		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050785-001	7217430	2020-04-04	U-926	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050785-001	7250176	2020-04-04	U-926		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050785-001	6746692	2020-04-04		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050785-001	6783773	2020-04-04		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050785-001	6878386	2020-04-04	U-926		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050785-001	7217430	2020-04-04	U-926	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050785-001	7250176	2020-04-04	U-926		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050785-001	6746692	2020-04-04		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050785-001	6783773	2020-04-04		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050785-001	6878386	2020-04-04	U-926		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050785-001	7217430	2020-04-04	U-926	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050785-001	7250176	2020-04-04	U-926		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050785-001	6746692	2020-04-04		Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050785-001	6783773	2020-04-04		Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050785-001	6878386	2020-04-04	U-926		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050785-001	7217430	2020-04-04	U-926	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050785-001	7250176	2020-04-04	U-926		`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Amoxicillin and Clavulanate Potassium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMOXICILLIN	562.5 mg/1
CLAVULANATE POTASSIUM	62.5 mg/1
AMOXICILLIN SODIUM	437.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
804826J2HU	Internal UNII lookup
Q42OMW3AT8	Internal UNII lookup
544Y3D6MYH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
617995	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
45c60b69-1b65-01ed-e063-6294a90a57be	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
81964-220-28	Amoxicillin and Clavulanate Potassium	28 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	28		1
81964-220-40	Amoxicillin and Clavulanate Potassium	40 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	40		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81964-220-28	EA - Each	81964-220	210551a0-355e-45ff-9119-c1191321167c	1	2026-02-05
81964-220-40	EA - Each	81964-220	aeb365e3-fb08-4a6f-bcb3-ce1ed9dab814	1	2026-02-05

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 · 1 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	USAntibiotics, LLC	45c60b69-1b65-01ed-e063-6294a90a57be	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050785 application number: NDA050785 ndc (product): 81964-220

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
544Y3D6MYH	AMOXICILLIN SODIUM	34642-77-8	AMOXICILLIN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
617995	amoxicillin 1000 MG / clavulanate potassium 62.5 MG 12HR Extended Release Oral Tablet	PSN	45c60b69-1b65-01ed-e063-6294a90a57be	1
617995	12 HR amoxicillin 1000 MG / clavulanate 62.5 MG Extended Release Oral Tablet	SCD	45c60b69-1b65-01ed-e063-6294a90a57be	1
617995	amoxicillin 1000 MG / clavulanate 62.5 MG 12 HR Extended Release Oral Tablet	SY	45c60b69-1b65-01ed-e063-6294a90a57be	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
81964-220-28	81964022028	28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (81964-220-28)	2025-12-15	No	No	Current
81964-220-40	81964022040	40 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (81964-220-40)	2025-12-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium	USAntibiotics, LLC	2026-07-07	HUMAN PRESCRIPTION DRUG LABEL	2