Amoxicillin and Clavulanate Potassium

Product NDC
71205-651
Requested package NDC
71205-651-10
11-digit product format
712050651
Labeler code
71205
Product ID
71205-651_f636413f-82e5-446f-94cc-b4841bdedb33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065063
Marketing category
ANDA
Marketing start
2020-05-01
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
875; 125 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
2026-12-31
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-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…

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin and Clavulanate Potassium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN875 mg/1
CLAVULANATE POTASSIUM125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
804826J2HUInternal UNII lookup
Q42OMW3AT8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
562508Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f636413f-82e5-446f-94cc-b4841bdedb33Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
ebb3e917-326a-9e18-0354-a19c9f63a2f3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-651-10Amoxicillin and Clavulanate Potassium10 in 1 BOTTLETABLET, FILM COATED101
71205-651-20Amoxicillin and Clavulanate Potassium20 in 1 BOTTLETABLET, FILM COATED201
71205-651-30Amoxicillin and Clavulanate Potassium30 in 1 BOTTLETABLET, FILM COATED301
71205-651-60Amoxicillin and Clavulanate Potassium60 in 1 BOTTLETABLET, FILM COATED601
71205-651-90Amoxicillin and Clavulanate Potassium90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-651-20EA - Each71205-651839ca1dc-66a8-482c-b067-a48da36d25b712022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-651AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, Legacy NDC, 5 package rows20220430_f636413f-82e5-446f-94cc-b4841bdedb33.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 · 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
ndc (package): 71205-651-10
ndc (product): 71205-651
ndc11 (package): 71205065110

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562508amoxicillin 875 MG / clavulanate potassium 125 MG Oral TabletPSNf636413f-82e5-446f-94cc-b4841bdedb331
562508amoxicillin 875 MG / clavulanate 125 MG Oral TabletSCDf636413f-82e5-446f-94cc-b4841bdedb331
562508amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral TabletSYf636413f-82e5-446f-94cc-b4841bdedb331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-651-107120506511010 TABLET, FILM COATED in 1 BOTTLE (71205-651-10) 2022-04-210000-00-00NoNoCurrent