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 4 of 10 · 199 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
REBIFINTERFERON BETA-1AEMD Serono, Inc.c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f2025-09-22Warnings, Adverse reactionsExact identifier
application number: BLA103780
ndc (package): 44087-0022-3
ndc (package): 44087-0044-3
ndc (package): 44087-8822-1
ndc (package): 44087-0022-9
ndc (package): 44087-3344-1
ndc (package): 44087-0044-9
ndc (package): 44087-3322-1
ndc (package): 44087-0188-1
ndc (package): 44087-3322-9
ndc (package): 44087-3344-9
ndc (product): 44087-0022
ndc (product): 44087-3344
ndc (product): 44087-8822
ndc (product): 44087-0188
ndc (product): 44087-0044
ndc (product): 44087-3322
ndc11 (package): 44087334401
rxcui: 1650012
rxcui: 795749
rxcui: 1650003
rxcui: 758030
rxcui: 1650004
rxcui: 1649994
rxcui: 1650268
rxcui: 758025
rxcui: 758029
rxcui: 1650011
rxcui: 758028
rxcui: 758027
rxcui: 1650282
rxcui: 1649996
rxcui: 795748
rxcui: 758032
spl id: 037d2645-544b-41bb-bea8-00b578366ac6
spl set id: c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f
unii: XRO4566Q4R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PerikabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCc2eb5522-8572-45f4-869d-42f9fd251bb62025-09-15Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
KabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCafeb4837-a759-4484-a76e-e04611c459e72025-09-11Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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