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 17 of 19 · 375 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINRising Pharma Holdings, Inc.bbe590a0-4196-4885-b679-cc1833af567f2024-02-27Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINSandoz Inc13bd4214-9b7f-425b-af5f-fc1ddc6782302024-02-22Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.116f655e-e32f-5030-e063-6394a90a64e52024-02-15Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP0d40bc70-8f47-48c2-a7c6-ba7db9cace742024-02-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINHikma Pharmaceuticals USA Inc.d46f1091-33dc-4f8f-9c34-75dcfedb4b4c2024-02-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINHikma Pharmaceuticals USA Inc.077f4a65-3cfb-4cb1-99f2-e27ffc5939c02024-02-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINAurobindo Pharma Limited7e3a4517-1934-4e03-b96b-4ad65ab076c52024-01-23Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLINAMOXICILLINDIRECT RX0173e9de-a995-4386-bb65-8fc2bbf347f92024-01-09Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINProficient Rx LP66404ced-5ef4-4a31-9276-8c6f86add61c2024-01-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINProficient Rx LPfcdaba34-373f-4d4e-8203-76f02e3bb00a2024-01-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions00fbd46e-05fd-4f8a-9f59-a7a4d01c8e542023-12-18Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutionscef5b1ae-8454-4e7a-8830-dd5d601c1d212023-12-09Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutionsca2886d0-7be7-4d41-bad5-df3ad44e0e7e2023-12-09Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions4eee2b38-ca84-421d-87e1-031bc5a3f3a72023-11-24Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions8bac30bb-1dbc-41de-ad50-0a1883f961982023-11-17Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions61f9224b-a91b-4154-a7f3-22c14601230f2023-10-31Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LPe05caabb-b95c-4e54-890e-bbc371a20fc32023-10-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions156ef8e9-b6e4-4512-865f-7139c90c8f9b2023-09-10Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMAsclemed USA, Inc.f14a8008-c0ff-4628-af99-e5f07b19df712023-09-06Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMAsclemed USA, Inc.8c4125d4-d074-40d4-9def-d3a528fc8c8e2023-09-06Warnings, Adverse reactionsExact identifier
unii: 804826J2HU

Reported adverse events (FAERS/openFDA)#

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