Amoxicillin and Clavulanate Potassium

Product NDC: 68071-1619
Requested package NDC: 68071-1619-1
11-digit product format: 680711619
Labeler code: 68071
Product ID: 68071-1619_1d4c3bbf-43f9-8590-e063-6294a90adebb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin and Clavulanate Potassium
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA065191
Marketing category: ANDA
Marketing start: 2007-12-01
Substance: AMOXICILLIN; CLAVULANIC ACID
Active strength: 400; 57 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

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
A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2005-01-25
A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2005-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065191-001	AB
A065191-002	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 · 82 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	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065191-001	AMOXICILLIN AND CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065191-002	AMOXICILLIN AND CLAVULANATE POTASSIUM	200MG/5ML;EQ 28.5MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-01-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A065191-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065191-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065191-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065191-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065191-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065191-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065191-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065191-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065191-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065191-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065191-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065191-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065191-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065191-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065191-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065191-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065191-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065191-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065191-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065191-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065191-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065191-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065191-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065191-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065191-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065191-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065191-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065191-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065191-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065191-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065191-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065191-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065191-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065191-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065191-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065191-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065191-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065191-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065191-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065191-002	AB	1	`782e0a99824c…`

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	400 mg/5mL
CLAVULANIC ACID	57 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
23521W1S24	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
617430	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
5d074fe6-1ee0-40d8-e053-2a91aa0a7549	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-07-15	These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP . Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP Initial U.S. Approval: 1984 Rx Only
2023-01-30	These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP . Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP Initial U.S. Approval: 1984 Rx Only
2021-02-11	These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP . Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP Initial U.S. Approval: 1984 Rx Only
2021-01-29	These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP . Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP Initial U.S. Approval: 1984 Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-1619-1	Amoxicillin and Clavulanate Potassium	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-1619	AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]	5	Current NDC, Legacy NDC, 1 package rows	20240716_5d074fe6-1ee0-40d8-e053-2a91aa0a7549.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 · 4 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	A-S Medication Solutions	483f6fca-e04e-4086-aa44-a361322b811d	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065191 application number: ANDA065191
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Hikma Pharmaceuticals USA Inc.	240bcdcb-31d9-40a0-87e1-bd16264a2e20	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065191 application number: ANDA065191
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	NuCare Pharmaceuticals,Inc.	5d074fe6-1ee0-40d8-e053-2a91aa0a7549	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065191 application number: ANDA065191 ndc (package): 68071-1619-1 ndc (product): 68071-1619 ndc11 (package): 68071161901
Amoxicillin and Clavulanate Potassium	AMOXICILLIN AND CLAVULANATE POTASSIUM	Proficient Rx LP	4655e0ea-f7d5-4f7c-bf7b-266337bc05b8	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065191 application number: ANDA065191

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
804826J2HU	AMOXICILLIN	61336-70-7	AMOXICILLIN
23521W1S24	CLAVULANIC ACID	58001-44-8	CLAVULANIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
617430	amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral Suspension	PSN	5d074fe6-1ee0-40d8-e053-2a91aa0a7549	5
617430	amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral Suspension	SCD	5d074fe6-1ee0-40d8-e053-2a91aa0a7549	5
617430	amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral Suspension	SY	5d074fe6-1ee0-40d8-e053-2a91aa0a7549	5
617430	amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral Suspension	SY	5d074fe6-1ee0-40d8-e053-2a91aa0a7549	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-1619-1	68071161901	100 mL in 1 BOTTLE (68071-1619-1)	100 ml	2017-11-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin and Clavulanate Potassium	NuCare Pharmaceuticals,Inc.	2024-07-15	HUMAN PRESCRIPTION DRUG LABEL	5