Amoxicillin and Clavulanate Potassium

Product NDC: 0781-6139
11-digit product format: 007816139
Labeler code: 0781
Product ID: 0781-6139_a64b73f7-9181-47db-9150-8ca6d2fbd189
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: SUSPENSION
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA065358
Marketing category: ANDA
Marketing start: 2007-08-13
Substance: AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength: 600; 42.9 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: 2026-12-31
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
A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2007-08-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065358-001	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065358-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-08-13	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A065358-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065358-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065358-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065358-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065358-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065358-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065358-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065358-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065358-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065358-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065358-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065358-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065358-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065358-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065358-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065358-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065358-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065358-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065358-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065358-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065358-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065358-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065358-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065358-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065358-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065358-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065358-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065358-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065358-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065358-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065358-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065358-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065358-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065358-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065358-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065358-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065358-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065358-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065358-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065358-001	AB	1	`f41ea6bd6efb…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMOXICILLIN	600 mg/5mL
CLAVULANATE POTASSIUM	42.9 mg/5mL

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
617993	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
99b7f40a-06f9-4b97-8eee-8e61e5106aad	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	SPL version
0781-6139-48	Amoxicillin and Clavulanate Potassium	200 mL in 1 BOTTLE, DISPENSING	SUSPENSION	200	15
0781-6139-54	Amoxicillin and Clavulanate Potassium	125 mL in 1 BOTTLE, DISPENSING	SUSPENSION	125	15
0781-6139-57	Amoxicillin and Clavulanate Potassium	75 mL in 1 BOTTLE, DISPENSING	SUSPENSION	75	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-6139-48	ML - Milliliter	0781-6139	958f4fed-7ccd-4c99-820d-bb5f5acda6f6	1	2012-07-24
0781-6139-54	ML - Milliliter	0781-6139	0a9c61af-f2ea-4910-8330-9431ba07c2fe	1	2012-07-24
0781-6139-57	ML - Milliliter	0781-6139	b05caa56-c92b-418c-b607-20dfb9ab2725	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]	8
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]	8
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]	8
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]	8
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]	8
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]	8
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]	8
ORANGE	INACTIVE INGREDIENT	5EVU04N5QU	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]	8
RASPBERRY	INACTIVE INGREDIENT	4N14V5R27W	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]	8
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]	8
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]	8
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]	8
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]	2
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]	2
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
AMOXICILLIN	ACTIVE MOIETY	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]	2
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]	2
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]	2
CITRIC ACID	INACTIVE INGREDIENT	2968PHW8QP	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]	2
ORANGE	INACTIVE INGREDIENT	5EVU04N5QU	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
RASPBERRY	INACTIVE INGREDIENT	4N14V5R27W	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]	2
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-6139	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [SANDOZ INC]	15	Current NDC, Legacy NDC, 3 package rows	20250411_99b7f40a-06f9-4b97-8eee-8e61e5106aad.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 · 3 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.	720ee5cf-1962-423b-ac81-6dd4f02b9206	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065358 application number: ANDA065358
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Sandoz Inc	99b7f40a-06f9-4b97-8eee-8e61e5106aad	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065358 application number: ANDA065358 ndc (product): 0781-6139
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	474c822b-dc3d-4a55-8159-2b4b799d535b	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065358 application number: ANDA065358

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
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension	PSN	99b7f40a-06f9-4b97-8eee-8e61e5106aad	15
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	99b7f40a-06f9-4b97-8eee-8e61e5106aad	15
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	99b7f40a-06f9-4b97-8eee-8e61e5106aad	15
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	99b7f40a-06f9-4b97-8eee-8e61e5106aad	15
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension	PSN	720ee5cf-1962-423b-ac81-6dd4f02b9206	5
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	720ee5cf-1962-423b-ac81-6dd4f02b9206	5
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	720ee5cf-1962-423b-ac81-6dd4f02b9206	5
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	720ee5cf-1962-423b-ac81-6dd4f02b9206	5
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension	PSN	b58ec5f9-0715-4562-9aeb-915329a4eef8	2
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension	PSN	be64cd87-af1b-4beb-957f-963b61fd95bf	2
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension	PSN	474c822b-dc3d-4a55-8159-2b4b799d535b	2
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	474c822b-dc3d-4a55-8159-2b4b799d535b	2
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	be64cd87-af1b-4beb-957f-963b61fd95bf	2
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	b58ec5f9-0715-4562-9aeb-915329a4eef8	2
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	be64cd87-af1b-4beb-957f-963b61fd95bf	2
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	b58ec5f9-0715-4562-9aeb-915329a4eef8	2
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	474c822b-dc3d-4a55-8159-2b4b799d535b	2
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	b58ec5f9-0715-4562-9aeb-915329a4eef8	2
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	be64cd87-af1b-4beb-957f-963b61fd95bf	2
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	474c822b-dc3d-4a55-8159-2b4b799d535b	2
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension	PSN	9f18d271-7cd8-4a4e-8087-6f11eddf0107	1
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	9f18d271-7cd8-4a4e-8087-6f11eddf0107	1
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	9f18d271-7cd8-4a4e-8087-6f11eddf0107	1
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	9f18d271-7cd8-4a4e-8087-6f11eddf0107	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-6139-48	00781613948	200 mL in 1 BOTTLE, DISPENSING (0781-6139-48)	200 ml	2007-08-13	0000-00-00	No	No	Current
0781-6139-54	00781613954	125 mL in 1 BOTTLE, DISPENSING (0781-6139-54)	125 ml	2007-08-13	0000-00-00	No	No	Current
0781-6139-57	00781613957	75 mL in 1 BOTTLE, DISPENSING (0781-6139-57)	75 ml	2007-08-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium	Preferred Pharmaceuticals Inc.	2026-03-04	HUMAN PRESCRIPTION DRUG LABEL	5
Amoxicillin and Clavulanate Potassium	Sandoz Inc	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	15
Amoxicillin and Clavulanate Potassium	Proficient Rx LP	2024-08-01	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin and Clavulanate Potassium	Aidarex Pharmaceuticals LLC	2018-08-20	HUMAN PRESCRIPTION DRUG LABEL	1
AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, USP	Physicians Total Care, Inc.	2013-02-20	HUMAN PRESCRIPTION DRUG LABEL	2
AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION USP	Rebel Distributors Corp.	2010-09-14	HUMAN PRESCRIPTION DRUG LABEL	2