FDA.reportPublic FDA data

NDC 44087-3344-01 - Rebif

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
44087-3344
Requested NDC
44087-3344-01
Package NDCs from labels
44087-3344-9, 44087-3344-1, 44087-3344-01
Manufacturer
EMD Serono, Inc.
Effective date
2025-09-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rebif - EMD Serono, Inc.EMD Serono, Inc.2025-09-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44087-3344-1REBIF REBIDOSE12 in 1 CARTONINJECTION, SOLUTION1227
44087-3344-9REBIF REBIDOSE0.5 mL in 1 PACKAGEINJECTION, SOLUTION0.527

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44087-3344REBIF (INTERFERON BETA-1A) KIT REBIF REBIDOSE (INTERFERON BETA-1A) KIT REBIF (INTERFERON BETA-1A ) INJECTION, SOLUTION REBIF (INTERFERON BETA-1A) INJECTION, SOLUTION REBIF REBIDOSE (INTERFERON BETA-1A ) INJECTION, SOLUTION [EMD SERONO, INC.]26Current NDC, Legacy NDC, 2 package rows20230806_c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44087-3344-1ML - Milliliter44087-3344fe2d274f-23ca-44af-a1eb-7e505905fdc412013-03-03
44087-3344-9ML - Milliliter44087-3344180d20dd-ee29-46bf-8ce4-43cf982a1b8a12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INTERFERON BETA-1AACTIVE INGREDIENTXRO4566Q4RREBIF (INTERFERON BETA-1A) KIT REBIF REBIDOSE (INTERFERON BETA-1A) KIT REBIF (INTERFERON BETA-1A ) INJECTION, SOLUTION REBIF (INTERFERON BETA-1A) INJECTION, SOLUTION REBIF REBIDOSE (INTERFERON BETA-1A ) INJECTION, SOLUTION [EMD SERONO, INC.]11
INTERFERON BETA-1AACTIVE MOIETYXRO4566Q4RREBIF (INTERFERON BETA-1A) KIT REBIF REBIDOSE (INTERFERON BETA-1A) KIT REBIF (INTERFERON BETA-1A ) INJECTION, SOLUTION REBIF (INTERFERON BETA-1A) INJECTION, SOLUTION REBIF REBIDOSE (INTERFERON BETA-1A ) INJECTION, SOLUTION [EMD SERONO, INC.]11
ALBUMIN HUMANINACTIVE INGREDIENTZIF514RVZRREBIF (INTERFERON BETA-1A) KIT REBIF REBIDOSE (INTERFERON BETA-1A) KIT REBIF (INTERFERON BETA-1A ) INJECTION, SOLUTION REBIF (INTERFERON BETA-1A) INJECTION, SOLUTION REBIF REBIDOSE (INTERFERON BETA-1A ) INJECTION, SOLUTION [EMD SERONO, INC.]11
MANNITOLINACTIVE INGREDIENT3OWL53L36AREBIF (INTERFERON BETA-1A) KIT REBIF REBIDOSE (INTERFERON BETA-1A) KIT REBIF (INTERFERON BETA-1A ) INJECTION, SOLUTION REBIF (INTERFERON BETA-1A) INJECTION, SOLUTION REBIF REBIDOSE (INTERFERON BETA-1A ) INJECTION, SOLUTION [EMD SERONO, INC.]11
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BREBIF (INTERFERON BETA-1A) KIT REBIF REBIDOSE (INTERFERON BETA-1A) KIT REBIF (INTERFERON BETA-1A ) INJECTION, SOLUTION REBIF (INTERFERON BETA-1A) INJECTION, SOLUTION REBIF REBIDOSE (INTERFERON BETA-1A ) INJECTION, SOLUTION [EMD SERONO, INC.]11
WATERINACTIVE INGREDIENT059QF0KO0RREBIF (INTERFERON BETA-1A) KIT REBIF REBIDOSE (INTERFERON BETA-1A) KIT REBIF (INTERFERON BETA-1A ) INJECTION, SOLUTION REBIF (INTERFERON BETA-1A) INJECTION, SOLUTION REBIF REBIDOSE (INTERFERON BETA-1A ) INJECTION, SOLUTION [EMD SERONO, INC.]11

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 10 of 10 · 199 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
InterSolPLATELET ADDITIVE 3Fenwal, Inc.e4f06c0b-7cb1-49c9-97a4-2cfc212984952021-11-16Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
Solucion InterSolSOLUCION ADITIVA PARA PLAQUETAS 3Fenwal, Inc.d5eaf5f4-67d3-4475-af9a-f5b0f882f5d12021-10-04Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
CLINIMIX ELEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSEBaxter Healthcare Company8469d6fb-d6ef-476f-8cc3-0905192de0a82021-04-13Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
InterSolPLATELET ADDITIVE 3Fenwal, Inc.a00c4a93-cde2-4753-81f7-0d6fee9fb6902020-10-20Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Isolyte SSODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEB. Braun Medical Inc.7e8fe27f-ff82-48c1-9bf6-3c589c8e985d2020-05-14Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plasma-Lyte ASODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEBaxter Healthcare Corporation6ec9e61c-2c26-402f-8604-f446b2e340582019-08-05Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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