Amoxicillin and Clavulanate Potassium

Product NDC: 85766-123
11-digit product format: 857660123
Labeler code: 85766
Product ID: 85766-123_50322015-adbe-6d1c-e063-6294a90a508f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: TABLET, MULTILAYER, EXTENDED RELEASE
Route: ORAL
Labeler: Sportpharm LLC
Application: ANDA090227
Marketing category: ANDA
Marketing start: 2010-04-21
Substance: CLAVULANATE POTASSIUM; AMOXICILLIN; AMOXICILLIN SODIUM
Active strength: 62.5; 562.5; 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
A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090227-001	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	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-04-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2010-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2010-04-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2010-04-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2010-04-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2010-04-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090227-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	1GM;EQ 62.5MG BASE	TABLET, EXTENDED RELEASE / ORAL		RS	2010-04-21	`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	A090227-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090227-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090227-001	AB	1	`011fe1cb6892…`
2019-12-13 00:20 UTC	2019-12	A090227-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090227-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090227-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090227-001	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090227-001	AB	1	`a50c72e98297…`

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
CLAVULANATE POTASSIUM	62.5 mg/1
AMOXICILLIN	562.5 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
Q42OMW3AT8	Internal UNII lookup
804826J2HU	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
cd7d2c0c-bf58-457a-b3d1-bb4c167cd127	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
85766-123-28	Amoxicillin and Clavulanate Potassium	28 in 1 BOTTLE	TABLET, MULTILAYER, EXTENDED REL	28		2

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 · 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	Sportpharm LLC	cd7d2c0c-bf58-457a-b3d1-bb4c167cd127	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090227 application number: ANDA090227 ndc (product): 85766-123
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Sandoz Inc	e41387c8-2c74-4990-831f-64dc921ee138	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090227 application number: ANDA090227

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q42OMW3AT8	CLAVULANATE POTASSIUM	61177-45-5	CLAVULANATE POTASSIUM
804826J2HU	AMOXICILLIN	61336-70-7	AMOXICILLIN
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	cd7d2c0c-bf58-457a-b3d1-bb4c167cd127	2
617995	12 HR amoxicillin 1000 MG / clavulanate 62.5 MG Extended Release Oral Tablet	SCD	cd7d2c0c-bf58-457a-b3d1-bb4c167cd127	2
617995	amoxicillin 1000 MG / clavulanate 62.5 MG 12 HR Extended Release Oral Tablet	SY	cd7d2c0c-bf58-457a-b3d1-bb4c167cd127	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
85766-123-28	85766012328	28 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (85766-123-28)	2025-11-06	No	No	Current