FDA.reportPublic FDA data

NDC 67296-0616-7 - Amoxicillin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
67296-0616
Requested NDC
67296-0616-7
Package NDCs from labels
67296-0616-7, 67296-0616-1, 67296-0616-2, 67296-0616-6
Manufacturer
Redpharm Drug
Effective date
2023-11-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amoxicillin - Redpharm DrugRedpharm Drug2023-11-28HUMAN PRESCRIPTION DRUG LABEL
Amoxicillin - RedPharm Drug Inc. | Aurobindo Pharma LimitedRedPharm Drug Inc. | Aurobindo Pharma Limited2011-07-01Human Prescription Drug Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-0616-12019-10-29C16284748780-1960f7f55-d63d-8e05-e053-dbdaa90a074aAmoxicillin Capsules, USP
67296-0616-22019-10-29C16284748780-1960f7f55-d63d-8e05-e053-dbdaa90a074aAmoxicillin Capsules, USP
67296-0616-62019-10-29C16284748780-1960f7f55-d63d-8e05-e053-dbdaa90a074aAmoxicillin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0616-1Amoxicillin30 in 1 BOTTLECAPSULE307
67296-0616-2Amoxicillin20 in 1 BOTTLECAPSULE207
67296-0616-6Amoxicillin21 in 1 BOTTLECAPSULE217
67296-0616-7Amoxicillin42 in 1 BOTTLECAPSULE421

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0616AMOXICILLIN CAPSULE [REDPHARM DRUG INC.]7Legacy NDC, 3 package rows20110713_6136dcbf-9bde-4b5b-82b3-d7cb8bdb817b.zip
67296-0616AMOXICILLIN CAPSULE [REDPHARM DRUG]1Legacy NDC, 1 package rows20240112_0b3d9a43-8b11-a622-e063-6294a90aadfc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]7
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [REDPHARM DRUG INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]7
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]7
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [REDPHARM DRUG INC.]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]7

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 3 of 120 · 2,399 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINRedpharm Drug57f5652d-ee50-eb7e-e063-6394a90a7b662026-08-01Warnings, Adverse reactionsExact identifier
application number: ANDA065271
rxcui: 308182
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.2c7a4de8-002a-472c-90d8-4c39a1f188c32026-07-31Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINRedpharm Drug57e56202-950b-10f6-e063-6394a90a49122026-07-31Warnings, Adverse reactionsExact identifier
application number: ANDA065271
rxcui: 308191
unii: 804826J2HU
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
AmoxicillinAMOXICILLINNuCare Pharmaceuticals, Inc.4a402dba-c255-5db8-e054-00144ff8d46c2026-07-24Warnings, Adverse reactionsExact identifier
application number: ANDA065271
rxcui: 308191
unii: 804826J2HU
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
amoxicillin and clavulanate potassiumAMOXICILLIN AND CLAVULANATE POTASSIUMChartwell RX, LLC00b86913-50c8-443f-8467-f4f499d358af2026-07-23Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
AmoxicillinAMOXICILLINREMEDYREPACK INC.a2c91cf0-a4e4-44c0-b712-bee63dd6c22b2026-07-22Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
AmoxicillinAMOXICILLINREMEDYREPACK INC.102c62ca-da20-4866-84a8-e3513824af4a2026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 308191
unii: 804826J2HU
AmoxicillinAMOXICILLINREMEDYREPACK INC.9618d038-e880-47f6-b8d7-bbf8ab35364d2026-07-21Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
AmoxicillinAMOXICILLINHAWAII REPACK, INC.bf130964-8386-4ab7-8d3b-fb0174670afc2026-07-17Warnings, Adverse reactionsExact identifier
application number: ANDA065271
rxcui: 308191
unii: 804826J2HU
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.18a4f555-a537-4c40-9bb2-dc3bd782fa272026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 308191
unii: 804826J2HU
VOQUEZNA DUAL PAKVONOPRAZAN FUMARATE AND AMOXICILLINPhathom Pharmaceuticals Inc.0cb2ee04-8581-46c8-a781-7be170ab5c862026-07-16Warnings, Adverse reactionsExact identifier
rxcui: 308191
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.1127a41b-14a1-4fe8-ae37-67ea5d7603012026-07-16Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.6e1c6209-660f-4043-b6a6-eac5f7665ef92026-07-15Warnings, Adverse reactionsExact identifier
unii: 804826J2HU

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.