FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
68071-4056
Requested package NDC
68071-4056-2
11-digit product format
680714056
Labeler code
68071
Product ID
68071-4056_bb2bf1f1-be82-f4cf-e053-2995a90afd0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065101
Marketing category
ANDA
Marketing start
2002-10-31
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
500 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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68071-405668071-4056-2DDiscontinued by firm2026-08-03

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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065101-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-303f01610625f2…
2019-09-15 20:21 UTC2019-09A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30cb3db0bc1861…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065101-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065101-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065101-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065101-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065101-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065101-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065101-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065101-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065101-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065101-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065101-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065101-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065101-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065101-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065101-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065101-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065101-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065101-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065101-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065101-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065101-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065101-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065101-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065101-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065101-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065101-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065101-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065101-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065101-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065101-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065101-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065101-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065101-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065101-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065101-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065101-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065101-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065101-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065101-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065101-001AB1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-07-18These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable). AMOXICILLIN AND CLAVULANAT
2023-01-30These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable). AMOXICILLIN AND CLAVULANAT
2021-02-12These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable). AMOXICILLIN AND CLAVULANAT
2021-01-29These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable). AMOXICILLIN AND CLAVULANAT

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.cc445a39-d84c-4b76-9fb8-ae302e7cd96b2025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065101
application number: ANDA065101
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.0425932a-f6e1-49a6-8480-720f179ace142025-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065101
application number: ANDA065101
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP482511ed-4531-45ec-a4eb-c600aeb033252024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065101
application number: ANDA065101
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMTeva Pharmaceuticals USA, Inc.963e7bea-ff5d-420a-9cb2-e4aefb534b332024-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065101
application number: ANDA065101
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMAsclemed USA, Inc.8c4125d4-d074-40d4-9def-d3a528fc8c8e2023-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065101
application number: ANDA065101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4056-26807140560220 TABLET, FILM COATED in 1 BOTTLE (68071-4056-2) 2017-08-170000-00-00NoNoCurrent