Amoxicillin and Clavulanate Potassium

Product NDC
55700-444
11-digit product format
557000444
Labeler code
55700
Product ID
55700-444_a2a7689f-bb0d-4740-8e86-a27824d887e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA065063
Marketing category
ANDA
Marketing start
2016-06-02
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
875 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
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-444DDiscontinued by firm2026-08-03
excluded packagepackage55700-44455700-444-20DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 14 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct55700-444DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-44455700-444-20DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct55700-444DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-44455700-444-20DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct55700-444DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-44455700-444-20DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct55700-444DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-44455700-444-20DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct55700-444DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-44455700-444-20DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct55700-444DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-44455700-444-20DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct55700-444DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-44455700-444-20DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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
A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065063-001AB

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 UTC2026-02A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-143f01610625f2…
2019-09-15 20:21 UTC2019-09A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065063-001AMOXICILLIN AND CLAVULANATE POTASSIUM875MG;EQ 125MG BASETABLET / ORALABRS2002-03-14cb3db0bc1861…

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 UTC2026-02A065063-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065063-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065063-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065063-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065063-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065063-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065063-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065063-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065063-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065063-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065063-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065063-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065063-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065063-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065063-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065063-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065063-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065063-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065063-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065063-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065063-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065063-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065063-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065063-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065063-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065063-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065063-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065063-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065063-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065063-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065063-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065063-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065063-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065063-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065063-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065063-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065063-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065063-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065063-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065063-001AB1cb3db0bc1861…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.c88b2b50-c664-43b3-9c37-f134a329dc212026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065063
application number: ANDA065063
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals, Inc.377abca8-7076-9ad0-e063-6294a90aa5dc2025-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065063
application number: ANDA065063
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals, Inc.348f7f77-ba7e-5dd9-e063-6294a90a09912025-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065063
application number: ANDA065063
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSandoz Inc7cba82f0-9886-46e9-8dbd-43a448aade292025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065063
application number: ANDA065063
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals, Inc.31d00820-1c20-d52b-e063-6394a90ac3122025-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065063
application number: ANDA065063
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.f9b4d263-bc5b-6065-e053-6394a90a5e352025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065063
application number: ANDA065063
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMAsclemed USA, Inc.a94cfba3-27ed-46a3-81ef-e9b80187c2072024-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065063
application number: ANDA065063
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepack917a76e9-eb2b-4d49-9418-ff919a73cfad2024-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065063
application number: ANDA065063
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LPa0d22635-0e11-448d-b151-6f6168c657232022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065063
application number: ANDA065063
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP5b68b2bf-b581-4372-87be-a6394ee569612022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065063
application number: ANDA065063
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LPf636413f-82e5-446f-94cc-b4841bdedb332022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065063
application number: ANDA065063

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-444-20EA - Each55700-444b2ab3a79-cb5e-4ff0-a040-be5bc97690ac12016-12-07