Amoxicillin and Clavulanate Potassium

Product NDC: 43858-603
11-digit product format: 438580603
Labeler code: 43858
Product ID: 43858-603_695710cf-342f-4ecd-822c-12b843ddb9b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Sandoz GmbH
Application: ANDA065065
Marketing category: ANDA
Marketing start: 2015-10-21
Marketing end: 0000-00-00
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 400 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: 2020-12-31
Current FDA listing: Historical FDA.report record

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
A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL			2002-04-18
A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL			2002-04-18

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065065-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG;EQ 28.5MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065065-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG;EQ 57MG BASE	TABLET, CHEWABLE / ORAL	2002-04-18	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

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 AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
BANANA	INACTIVE INGREDIENT	4AJZ4765R9	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
ORANGE	INACTIVE INGREDIENT	5EVU04N5QU	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
SUCCINIC ACID	INACTIVE INGREDIENT	AB6MNQ6J6L	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [SANDOZ GMBH]	10

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
43858-603-66	43858060366	5 BLISTER PACK in 1 CARTON (43858-603-66) > 4 TABLET, CHEWABLE in 1 BLISTER PACK	5 blister pack	2015-10-21	0000-00-00	No	No	Current

Amoxicillin and Clavulanate Potassium

Orange Book products#

Observed Orange Book product history#

Reported adverse events (FAERS/openFDA)#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#