Amoxicillin and Clavulanate Potassium

Product NDC: 68788-0483
11-digit product format: 687880483
Labeler code: 68788
Product ID: 68788-0483_e51cf486-cd20-464d-a9e5-917ee699ad43
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA201091
Marketing category: ANDA
Marketing start: 2011-11-07
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2011-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201091-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201091-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	600MG/5ML;EQ 42.9MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2011-12-20	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201091-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201091-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201091-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201091-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201091-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201091-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201091-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201091-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201091-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201091-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201091-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201091-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201091-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201091-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201091-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201091-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201091-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201091-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201091-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201091-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201091-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201091-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201091-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201091-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201091-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201091-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201091-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201091-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201091-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201091-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201091-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201091-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201091-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201091-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201091-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201091-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201091-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201091-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201091-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201091-001	AB	1	`cb3db0bc1861…`

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
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
22a387bd-92ce-4ebc-b475-20d7750a2507	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
68788-0483-1	Amoxicillin and Clavulanate Potassium	125 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	125		13
68788-0483-7	Amoxicillin and Clavulanate Potassium	75 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	75		13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	2
CLAVULANATE POTASSIUM	ACTIVE INGREDIENT	Q42OMW3AT8	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	2
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	2
CLAVULANIC ACID	ACTIVE MOIETY	23521W1S24	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	2
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	2
STRAWBERRY	INACTIVE INGREDIENT	4J2TY8Y81V	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	2
SUCCINIC ACID	INACTIVE INGREDIENT	AB6MNQ6J6L	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-0483	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	11	Current NDC, Legacy NDC, 2 package rows	20240214_22a387bd-92ce-4ebc-b475-20d7750a2507.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 · 12 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	Redpharm Drug	5250085e-5509-c577-e063-6294a90a9b87	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Preferred Pharmaceuticals, Inc.	22a387bd-92ce-4ebc-b475-20d7750a2507	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091 ndc (product): 68788-0483
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	bcd19a89-e9dc-b85f-e053-2a95a90a6f3e	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	2a376d67-0bf2-43a1-8ca3-73f90689c339	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	ebf49514-0bce-ac56-e053-2a95a90ae540	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	A-S Medication Solutions	ccb8bfb1-1303-4c2d-9106-78684e6b859f	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NorthStar Rx LLC	df4136c0-9efd-42c3-a487-e728e8b91275	2025-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Aurobindo Pharma Limited	5200ae31-8a79-45f9-84fc-98f8448483a7	2025-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	9ba5b2b2-3c27-a2a8-e053-2a95a90a97cd	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	a0ff848d-230a-ab6b-e053-2a95a90a8bb8	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	e05caabb-b95c-4e54-890e-bbc371a20fc3	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	bb75eb89-2579-4189-8dd2-40ae8727fe7c	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201091 application number: ANDA201091

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	22a387bd-92ce-4ebc-b475-20d7750a2507	13
617993	amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension	SCD	22a387bd-92ce-4ebc-b475-20d7750a2507	13
617993	amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension	SY	22a387bd-92ce-4ebc-b475-20d7750a2507	13
617993	amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension	SY	22a387bd-92ce-4ebc-b475-20d7750a2507	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-0483-1	68788048301	125 mL in 1 BOTTLE (68788-0483-1)	125 ml	2011-11-07	0000-00-00	No	No	Current
68788-0483-7	68788048307	75 mL in 1 BOTTLE (68788-0483-7)	75 ml	2011-11-07	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	13