Amoxicillin and Clavulanate Potassium

Product NDC: 0143-9853
11-digit product format: 001439853
Labeler code: 0143
Product ID: 0143-9853_45f95702-3be8-47a5-8de8-3b17457aa04a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: SUSPENSION
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA065373
Marketing category: ANDA
Marketing start: 2009-08-03
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
A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2007-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065373-001	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	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065373-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2007-11-09	`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	A065373-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065373-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065373-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065373-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065373-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065373-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065373-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065373-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065373-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065373-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065373-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065373-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065373-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065373-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065373-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065373-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065373-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065373-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065373-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065373-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065373-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065373-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065373-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065373-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065373-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065373-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065373-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065373-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065373-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065373-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065373-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065373-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065373-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065373-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065373-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065373-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065373-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065373-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065373-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065373-001	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
6339bcdb-060f-4558-9f42-6bf7f935e138	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
0143-9853-16	Amoxicillin and Clavulanate Potassium	125 mL in 1 BOTTLE	SUSPENSION	125	14
0143-9853-24	Amoxicillin and Clavulanate Potassium	200 mL in 1 BOTTLE	SUSPENSION	200	14
0143-9853-75	Amoxicillin and Clavulanate Potassium	75 mL in 1 BOTTLE	SUSPENSION	75	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9853-16	ML - Milliliter	0143-9853	53ec010b-87bd-4078-ab40-b5ad3076e2de	1	2012-07-24
0143-9853-24	ML - Milliliter	0143-9853	b2706ca9-6e05-443a-a0cb-b6375068e486	1	2012-07-24
0143-9853-75	ML - Milliliter	0143-9853	1ea30c59-be86-489d-9b4a-9eb4603f153d	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 [WEST-WARD PHARMACEUTICAL CORP]	5
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	5
AMOXICILLIN	ACTIVE MOIETY	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	5
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	5
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	5
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	5
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	5
SUCCINIC ACID	INACTIVE INGREDIENT	AB6MNQ6J6L	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	5
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9853	AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [HIKMA PHARMACEUTICALS USA INC.]	13	Current NDC, Legacy NDC, 3 package rows	20240625_6339bcdb-060f-4558-9f42-6bf7f935e138.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.	fc31a5df-aa1c-4b0f-8c64-a14236df4a02	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065373 application number: ANDA065373
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals Inc.	16915fe9-1ac9-4ebb-afc8-eeb89144f30c	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065373 application number: ANDA065373
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Hikma Pharmaceuticals USA Inc.	6339bcdb-060f-4558-9f42-6bf7f935e138	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065373 application number: ANDA065373 ndc (product): 0143-9853

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	ecbdb7e4-2a1c-4b72-9ae9-ed009c0eca1e	15
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	ecbdb7e4-2a1c-4b72-9ae9-ed009c0eca1e	15
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	ecbdb7e4-2a1c-4b72-9ae9-ed009c0eca1e	15
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	ecbdb7e4-2a1c-4b72-9ae9-ed009c0eca1e	15
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension	PSN	6339bcdb-060f-4558-9f42-6bf7f935e138	14
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	6339bcdb-060f-4558-9f42-6bf7f935e138	14
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	6339bcdb-060f-4558-9f42-6bf7f935e138	14
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	6339bcdb-060f-4558-9f42-6bf7f935e138	14
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension	PSN	fc31a5df-aa1c-4b0f-8c64-a14236df4a02	5
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	fc31a5df-aa1c-4b0f-8c64-a14236df4a02	5
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	fc31a5df-aa1c-4b0f-8c64-a14236df4a02	5
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	fc31a5df-aa1c-4b0f-8c64-a14236df4a02	5
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension	PSN	85f3972f-205e-4de6-b8ce-aa93cd1a0e2e	4
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	85f3972f-205e-4de6-b8ce-aa93cd1a0e2e	4
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	85f3972f-205e-4de6-b8ce-aa93cd1a0e2e	4
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	85f3972f-205e-4de6-b8ce-aa93cd1a0e2e	4
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension	PSN	16915fe9-1ac9-4ebb-afc8-eeb89144f30c	2
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	16915fe9-1ac9-4ebb-afc8-eeb89144f30c	2
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	16915fe9-1ac9-4ebb-afc8-eeb89144f30c	2
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	16915fe9-1ac9-4ebb-afc8-eeb89144f30c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9853-16	00143985316	125 mL in 1 BOTTLE (0143-9853-16)	125 ml	2009-08-03	0000-00-00	No	No	Current
0143-9853-24	00143985324	200 mL in 1 BOTTLE (0143-9853-24)	200 ml	2009-08-03	0000-00-00	No	No	Current
0143-9853-75	00143985375	75 mL in 1 BOTTLE (0143-9853-75)	75 ml	2009-08-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium	Preferred Pharmaceuticals Inc.	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	5
Amoxicillin and Clavulanate Potassium	Preferred Pharmaceuticals Inc.	2026-01-20	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin and Clavulanate Potassium	Hikma Pharmaceuticals USA Inc. \| Hikma Pharmaceuticals LLC	2025-02-28	HUMAN PRESCRIPTION DRUG LABEL	14
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL	A-S Medication Solutions	2021-02-22	HUMAN PRESCRIPTION DRUG LABEL	15
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL	NuCare Pharmaceuticals,Inc.	2021-02-11	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL	Preferred Pharmaceuticals Inc.	2016-12-07	HUMAN PRESCRIPTION DRUG LABEL	1
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL	Aidarex Pharmaceuticals LLC	2016-11-17	HUMAN PRESCRIPTION DRUG LABEL	4