FDA.reportPublic FDA data

REBIF REBIDOSE

Product NDC
44087-0188
11-digit product format
440870188
Labeler code
44087
Product ID
44087-0188_037d2645-544b-41bb-bea8-00b578366ac6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
INTERFERON BETA-1A
Dosage form
KIT
Route
SUBCUTANEOUS
Labeler
EMD Serono, Inc.
Application
BLA103780
Marketing category
BLA
Marketing start
2012-12-21
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
REBIF REBIDOSE
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXRO4566Q4R
Rxcui758025, 758027, 758028, 758029, 758030, 758032, 795748, 795749, 1649994, 1649996, 1650003, 1650004, 1650011, 1650012, 1650268, 1650282

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
326327f0-4d6d-4c84-bc6d-8d84a27e249fProduct name120191002
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44087-0188-1REBIF REBIDOSE1 in 1 CARTONKIT127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44087-0188-1ML - Milliliter44087-0188a63e0551-f191-4249-b05c-58abf63f766212013-03-03

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44087-0188REBIF (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, 1 package rows20230806_c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650282{6 (0.2 ML interferon beta-1a 0.044 MG/ML Auto-Injector [Rebif]) / 6 (0.5 ML interferon beta-1a 0.044 MG/ML Auto-Injector [Rebif]) } Pack [Rebif Rebidose]BPCKc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
795749{6 (0.2 ML interferon beta-1a 0.044 MG/ML Prefilled Syringe [Rebif]) / 6 (0.5 ML interferon beta-1a 0.044 MG/ML Prefilled Syringe [Rebif]) } Pack [Rebif Titration]BPCKc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
1650268{6 (0.2 ML interferon beta-1a 0.044 MG/ML Auto-Injector) / 6 (0.5 ML interferon beta-1a 0.044 MG/ML Auto-Injector) } PackGPCKc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
758030{6 (0.2 ML interferon beta-1a 0.044 MG/ML Prefilled Syringe) / 6 (0.5 ML interferon beta-1a 0.044 MG/ML Prefilled Syringe) } PackGPCKc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
1649994interferon beta-1a 22 MCG in 0.5 mL Auto-InjectorPSNc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
758029interferon beta-1a 22 MCG in 0.5 ML Prefilled SyringePSNc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
1650003interferon beta-1a 44 MCG in 0.5 mL Auto-InjectorPSNc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
758025interferon beta-1a 44 MCG in 0.5 ML Prefilled SyringePSNc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
1650268interferon beta-1a 8.8 MCG in 0.2 ML (6) Auto-Injector / interferon beta-1a 22 MCG in 0.5 ML (6) Auto-Injector PackPSNc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
758030interferon beta-1a 8.8 MCG in 0.2 ML (6) Prefilled Syringe / interferon beta-1a 22 MCG in 0.5 ML (6) Prefilled Syringe PackPSNc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
1650011Interferon beta-1a 8.8 MCG in 0.2 ML Auto-InjectorPSNc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
758028interferon beta-1a 8.8 MCG in 0.2 ML Prefilled SyringePSNc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
1649996Rebif 22 MCG in 0.5 ML Auto-InjectorPSNc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
758032Rebif 22 MCG in 0.5 ML Prefilled SyringePSNc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
1650004Rebif 44 MCG in 0.5 ML Auto-InjectorPSNc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
758027Rebif 44 MCG in 0.5 ML Prefilled SyringePSNc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
1650012Rebif 8.8 MCG in 0.2 ML Auto-InjectorPSNc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
795748Rebif 8.8 MCG in 0.2 ML Prefilled SyringePSNc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
1650282Rebif Rebidose Titration PackPSNc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
795749Rebif Titration PackPSNc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
16500120.2 ML interferon beta-1a 0.044 MG/ML Auto-Injector [Rebif]SBDc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
7957480.2 ML interferon beta-1a 0.044 MG/ML Prefilled Syringe [Rebif]SBDc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
16499960.5 ML interferon beta-1a 0.044 MG/ML Auto-Injector [Rebif]SBDc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
7580320.5 ML interferon beta-1a 0.044 MG/ML Prefilled Syringe [Rebif]SBDc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
16500040.5 ML interferon beta-1a 0.088 MG/ML Auto-Injector [Rebif]SBDc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
7580270.5 ML interferon beta-1a 0.088 MG/ML Prefilled Syringe [Rebif]SBDc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
16500110.2 ML interferon beta-1a 0.044 MG/ML Auto-InjectorSCDc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
7580280.2 ML interferon beta-1a 0.044 MG/ML Prefilled SyringeSCDc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
16499940.5 ML interferon beta-1a 0.044 MG/ML Auto-InjectorSCDc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
7580290.5 ML interferon beta-1a 0.044 MG/ML Prefilled SyringeSCDc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
16500030.5 ML interferon beta-1a 0.088 MG/ML Auto-InjectorSCDc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
7580250.5 ML interferon beta-1a 0.088 MG/ML Prefilled SyringeSCDc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
16500120.2 ML Rebif 0.044 MG/ML Auto-InjectorSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
7957480.2 ML Rebif 0.044 MG/ML Prefilled SyringeSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
16499960.5 ML Rebif 0.044 MG/ML Auto-InjectorSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
7580320.5 ML Rebif 0.044 MG/ML Prefilled SyringeSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
16500040.5 ML Rebif 0.088 MG/ML Auto-InjectorSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
7580270.5 ML Rebif 0.088 MG/ML Prefilled SyringeSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
758028interferon beta-1a 0.0088 MG per 0.2 ML Prefilled SyringeSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
758029interferon beta-1a 0.022 MG per 0.5 ML Prefilled SyringeSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
758025interferon beta-1a 0.044 MG per 0.5 ML Prefilled SyringeSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
1649994interferon beta-1a 22 MCG per 0.5 ML Auto-InjectorSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
758029interferon beta-1a 22 MCG per 0.5 ML Prefilled SyringeSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
1650003interferon beta-1a 44 MCG per 0.5 ML Auto-InjectorSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
758025interferon beta-1a 44 MCG per 0.5 ML Prefilled SyringeSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
1650011Interferon beta-1a 8.8 MCG in 0.2 ML Auto-InjectorSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
758028interferon beta-1a 8.8 MCG per 0.2 ML Prefilled SyringeSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
795748Rebif 0.0088 MG per 0.2 ML Prefilled SyringeSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
758032Rebif 0.022 MG per 0.5 ML Prefilled SyringeSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
758027Rebif 0.044 MG per 0.5 ML Prefilled SyringeSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
1649996Rebif 22 MCG per 0.5 ML Auto-InjectorSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
758032Rebif 22 MCG per 0.5 ML Prefilled SyringeSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
1650004Rebif 44 MCG per 0.5 ML Auto-InjectorSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
758027Rebif 44 MCG per 0.5 ML Prefilled SyringeSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
1650012Rebif 8.8 MCG per 0.2 ML Auto-InjectorSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
795748Rebif 8.8 MCG per 0.2 ML Prefilled SyringeSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
1650282Rebif Rebidose Titration PackSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
795749Rebif Titration PackSYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27
795749Rebif Titration Pack, (6 Rebif 8.8 MCG Prefilled Syringes & 6 Rebif 22 MCG Prefilled Syringes)SYc6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44087-0188-1440870188011 KIT in 1 CARTON (44087-0188-1) * .2 mL in 1 PACKAGE * .5 mL in 1 PACKAGE1 kit2012-12-210000-00-00NoNoCurrent