FDA.reportPublic FDA data

NDC 51311-203 - 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
51311-203
Package NDCs from labels
51311-203-50
Manufacturer
Virbac AH, Inc.
Effective date
2024-08-26
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 # 065-492 BIOMOX ® (amoxicillin tablets)Virbac AH, Inc.2024-08-26PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51311-203-50Biomox500 in 1 BOTTLETABLET50011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51311-203BIOMOX (AMOXICILLIN) TABLET [VIRBAC AH, INC.]111 package rows20240828_2f628ed5-75cb-47a1-a5e7-2902c6f3d336.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
amoxicillinACTIVE INGREDIENT804826J2HUBIOMOX (AMOXICILLIN) TABLET [VIRBAC AH, INC.]1
amoxicillinACTIVE MOIETY804826J2HUBIOMOX (AMOXICILLIN) TABLET [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 16 of 19 · 375 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AugmentinAMOXICILLIN AND CLAVULANATE POTASSIUMAllegis Holdings, LLC04a31a42-d79e-bbb4-e063-6394a90a63ee2024-05-16Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions2718248d-d948-466e-959b-1a972519f1082024-05-14Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions14a5f8c2-fdaf-4ad4-982b-c5aa128e242d2024-05-06Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions7db086c6-a56b-4848-9eec-abaaff9f5b6f2024-05-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutionsd5ecb620-5267-4dcf-be81-64c7766516f52024-05-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutionsa2a5bb34-671b-499c-b8b4-c40fb51af09a2024-04-30Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions3d8a700b-b23b-459a-a19a-213dd39b6a3a2024-04-30Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutionsefc66d77-1733-41e1-9aed-7c10a4b4ba962024-04-30Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions00cf4429-e37c-4490-b22d-3cd7961242962024-04-30Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions6a3d1af5-6e93-4f06-8d82-1c87290c46aa2024-04-30Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions1dc5cc5a-59ba-4bc9-b581-cb7b70ce26522024-04-30Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions322feb95-8bd4-440a-bda2-29ee19b112342024-04-15Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions4d0f063a-d896-4757-8f22-9614e2ad71d42024-04-11Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions73219f24-6eac-4472-b2a7-cad36936c1852024-04-11Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions26202694-cf20-4b08-90cc-70a3d30cbb0f2024-04-11Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNorthStar Rx LLC843f6053-63d9-47d2-81f1-b6aa78a7c20c2024-03-02Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMMedsource Pharmaceuticals12a00e7e-80f5-7c5e-e063-6394a90a68d22024-03-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINProficient Rx LP6a9cfa97-3715-4b75-a1e3-932a34a942d42024-03-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMMedsource Pharmaceuticals1275ad58-c53f-20d0-e063-6394a90a4a432024-02-28Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINHikma Pharmaceuticals USA Inc.c8591c2a-92ef-4432-b19a-bb46063047ee2024-02-28Warnings, Adverse reactionsExact identifier
unii: 804826J2HU

Reported adverse events (FAERS/openFDA)#

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