Amoxicillin and Clavulanate Potassium

Product NDC: 68788-8000
11-digit product format: 687888000
Labeler code: 68788
Product ID: 68788-8000_db2f8359-bd14-4ee6-9f4d-cce4f3a1cbe3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA065066
Marketing category: ANDA
Marketing start: 2021-08-10
Marketing end: 0000-00-00
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 200 mg/5mL; mg/5mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68788-8000		D	Discontinued by firm		2026-10-02
excluded package	package	68788-8000	68788-8000-1	D	Discontinued by firm		2026-10-02

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2002-06-05
A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2002-06-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A065066-001	AB
A065066-002	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 3 · 86 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	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065066-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065066-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2002-06-05	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A065066-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065066-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065066-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065066-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065066-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065066-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065066-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065066-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065066-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065066-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065066-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065066-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065066-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065066-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065066-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065066-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065066-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065066-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065066-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065066-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065066-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065066-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065066-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065066-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065066-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065066-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065066-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065066-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065066-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065066-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065066-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065066-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065066-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065066-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065066-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065066-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065066-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065066-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065066-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065066-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8000-1	ML - Milliliter	68788-8000	a4cc1cd5-c0e1-4ce3-b46d-4ffa0967c09b	1	2021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8000	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.]	5	Legacy NDC	20250125_51ee76f6-b699-4e50-b7a9-0477580d1f14.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 · 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	Sandoz Inc	7cba82f0-9886-46e9-8dbd-43a448aade29	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065066 application number: ANDA065066

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8000-1	68788800001	100 mL in 1 BOTTLE (68788-8000-1)	100 ml	2021-08-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium	Preferred Pharmaceuticals Inc.	2025-01-03	HUMAN PRESCRIPTION DRUG LABEL	5