FDA.reportPublic FDA data

NDC 49281-246 - IMOVAX RABIES

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
49281-246
Package NDCs from labels
49281-246-58
Manufacturer
Sanofi Vaccines US Inc. | Sanofi Winthrop Industrie
Effective date
2026-02-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IMOVAX RABIES - Sanofi Vaccines US Inc. | Sanofi Winthrop IndustrieSanofi Vaccines US Inc. | Sanofi Winthrop Industrie2026-02-02VACCINE LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49281-246-58IMOVAX RABIES1 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,1 mL2.5 [iU] in 1mL24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49281-246IMOVAX RABIES (RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) AND WATER) KIT [SANOFI PASTEUR INC.]20Unmatched20240801_ba8d4e72-f452-4859-ae6f-3644b4b0a78c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED)ACTIVE INGREDIENTC4HQF74XMWIMOVAX RABIES (RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) AND WATER) KIT [SANOFI PASTEUR INC.]6
RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED)ACTIVE MOIETYC4HQF74XMWIMOVAX RABIES (RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) AND WATER) KIT [SANOFI PASTEUR INC.]6
ALBUMIN (HUMAN)INACTIVE INGREDIENTZIF514RVZRIMOVAX RABIES (RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) AND WATER) KIT [SANOFI PASTEUR INC.]6
NEOMYCIN SULFATEINACTIVE INGREDIENT057Y626693IMOVAX RABIES (RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) AND WATER) KIT [SANOFI PASTEUR INC.]6

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 14 of 26 · 514 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Drs. pharmacy triple antibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENTOL PHARMA TECH, LLCbb730976-0045-c0ae-e053-2a95a90af34e2025-01-09WarningsExact identifier
unii: 057Y626693
Drs. Pharmacy Triple Antibiotic PlusBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEOL PHARMA TECH, LLC Drs PHARMACYd037bfb8-0d8c-4eda-e053-2995a90ae1f22025-01-09WarningsExact identifier
unii: 057Y626693
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Neomycin and Polymyxin B Sulfates and Bacitracin ZincNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINCBausch & Lomb Incorporatedf3231f1c-665e-4efa-baa1-83bf296b2f8f2025-01-02Warnings, Adverse reactionsExact identifier
unii: 057Y626693
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and HydrocortisoneNEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONEBausch & Lomb Incorporated3b00eb5c-dd98-467e-a883-04c37a8ecc422025-01-02Warnings, Adverse reactionsExact identifier
unii: 057Y626693
AVON HeXashield Triple Antibiotic with Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLTai Guk Pharm. Co., Ltd.8e0cb861-d8aa-1f71-e053-2a95a90aaa882025-01-01WarningsExact identifier
unii: 057Y626693
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA LLC087694c2-4b1b-e293-e063-6294a90a961f2024-12-31WarningsExact identifier
unii: 057Y626693
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATETRIFECTA PHARMACEUTICALS USA LLC0c017b10-29b6-e30f-e063-6294a90a8a3c2024-12-31WarningsExact identifier
unii: 057Y626693
Triple Antibiotic and Pain ReliefBACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINETrifecta Pharmaceutical USA LLC0bf08cf6-be3f-f9aa-e063-6294a90a43932024-12-31WarningsExact identifier
unii: 057Y626693
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONENEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLCf1a05d5f-74f2-17a1-e053-2995a90ab0e72024-12-31Warnings, Adverse reactionsExact identifier
unii: 057Y626693
ALBUMINEXALBUMIN HUMANBPL8428d373-f4b1-4e3b-bb19-ea89048f7c792024-12-31Warnings, Adverse reactionsExact identifier
unii: ZIF514RVZR
ALBUMINEXALBUMIN HUMANBPL167f48d0-8ae5-4f7e-b050-9673dad78acc2024-12-31Warnings, Adverse reactionsExact identifier
unii: ZIF514RVZR
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONENuCare Pharmaceuticals,Inc.a7e55c43-4345-4710-e053-2995a90aeee72024-12-30Warnings, Adverse reactionsExact identifier
unii: 057Y626693
TripleantibioticapainscaritchFAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINEHCLTrifecta Pharmaceutical USA LLC935106c6-8a9e-07fa-e053-2a95a90a24842024-12-20WarningsExact identifier
unii: 057Y626693

Reported adverse events (FAERS/openFDA)#

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