FDA.reportPublic FDA data

NDC 51311-300 - Biomox

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
51311-300
Package NDCs from labels
51311-300-15, 51311-300-30
Manufacturer
Virbac AH, Inc. | Medispray Laboratories Private Ltd | Centrient Pharmaceuticals Netherlands | Alcami Missouri Corporation | Alcami Carolinas Corporation
Effective date
2022-01-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Approved by FDA under NADA # 065-495 BIOMOX® (amoxicillin)Virbac AH, Inc. | Medispray Laboratories Private Ltd | Centrient Pharmaceuticals Netherlands | Alcami Missouri Corporation | Alcami Carolinas Corporation2022-01-05PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51311-300-15Biomox15 mL in 1 BOTTLE, DROPPERSUSPENSION155
51311-300-30Biomox30 mL in 1 BOTTLE, DROPPERSUSPENSION305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51311-300BIOMOX (AMOXICILLIN) SUSPENSION [VIRBAC AH, INC.]52 package rows20220106_b2a9380f-3dd5-4fc6-8f03-2d04e284e1cb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
amoxicillinACTIVE INGREDIENT804826J2HUBIOMOX (AMOXICILLIN) SUSPENSION [VIRBAC AH, INC.]1
amoxicillinACTIVE MOIETY804826J2HUBIOMOX (AMOXICILLIN) SUSPENSION [VIRBAC AH, INC.]1

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 4 of 19 · 375 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINCoupler LLC52bd03c6-528a-c443-e063-6394a90aad392026-05-26Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMRedpharm Drug5250085e-5509-c577-e063-6294a90a9b872026-05-21Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.5155ca5d-fe58-42b4-e063-6394a90ab1352026-05-21Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINBryant Ranch Prepackbe7d8459-b8e6-499a-ab87-99bd174925252026-05-08Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINQPharma, Inc60c788d1-6c91-4456-848a-893e649e90be2026-05-08Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINQPharma Incddd1307d-3216-0e59-e053-2995a90ad19d2026-05-08Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMCoupler LLC513b6211-c73b-7e66-e063-6394a90a2aa12026-05-07Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINCoupler LLC50fff2b8-8bf1-ff46-e063-6394a90a92132026-05-04Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMCoupler LLC5102cf09-9c52-ede4-e063-6394a90abd462026-05-04Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINCoupler LLC5037e2a5-52e9-caec-e063-6294a90ad8372026-04-28Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSportpharm LLCfabeca32-3f26-4b65-b8b6-5f0e23765ab02026-04-24Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSportpharm LLCcd7d2c0c-bf58-457a-b3d1-bb4c167cd1272026-04-24Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINCoupler LLC5020950a-b248-a463-e063-6294a90ae57f2026-04-23Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINAmerican Health Packagingd339ea0f-8797-460f-a3b7-b8455c2503662026-04-07Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINSportpharm LLC9bb2856b-feef-4063-befc-2dd9175028982026-03-20Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.c19b533a-907a-6350-e053-2a95a90a12442026-03-13Warnings, Adverse reactionsExact identifier
rxcui: 239191
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepackdfdde253-44b8-4074-b759-7bc40ea26cf92026-03-12Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMAmerican Health Packaging4966a3f2-eed2-4081-ba88-310a3d1964b42026-03-06Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.fc31a5df-aa1c-4b0f-8c64-a14236df4a022026-03-05Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.afef7c71-2d19-41ed-9213-b32ccc1bf1d32026-03-04Warnings, Adverse reactionsExact identifier
unii: 804826J2HU

Reported adverse events (FAERS/openFDA)#

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