NDC 75987-111

ACTIMMUNE

Interferon Gamma-1b

ACTIMMUNE is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Horizon Therapeutics Usa, Inc.. The primary component is Interferon Gamma-1b.

Product ID75987-111_10c38fa8-bbf3-40e5-83dc-bc105723a442
NDC75987-111
Product TypeHuman Prescription Drug
Proprietary NameACTIMMUNE
Generic NameInterferon Gamma-1b
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2013-12-01
Marketing CategoryBLA / BLA
Application NumberBLA103836
Labeler NameHorizon Therapeutics USA, Inc.
Substance NameINTERFERON GAMMA-1B
Active Ingredient Strength100 ug/.5mL
Pharm ClassesInterferon gamma [EPC],Interferon-gamma [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 75987-111-11

12 VIAL, SINGLE-USE in 1 CARTON (75987-111-11) > .5 mL in 1 VIAL, SINGLE-USE (75987-111-10)
Marketing Start Date2013-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 75987-111-10 [75987011110]

ACTIMMUNE INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103836
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-12-01

NDC 75987-111-11 [75987011111]

ACTIMMUNE INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103836
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-12-01

Drug Details

Active Ingredients

IngredientStrength
INTERFERON GAMMA-1B100 ug/.5mL

OpenFDA Data

SPL SET ID:5d0b1256-1981-4519-94f4-a4a2f98bd8a3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 240448
  • 751970
  • UPC Code
  • 0375987111118
  • Pharmacological Class

    • Interferon gamma [EPC]
    • Interferon-gamma [CS]

    NDC Crossover Matching brand name "ACTIMMUNE" or generic name "Interferon Gamma-1b"

    NDCBrand NameGeneric Name
    75987-111ACTIMMUNEInterferon gamma-1b
    17089-378GUNA-INF GAMMAINTERFERON GAMMA-1B

    Trademark Results [ACTIMMUNE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ACTIMMUNE
    ACTIMMUNE
    77792019 not registered Dead/Abandoned
    Active Organics, Inc.
    2009-07-29
    ACTIMMUNE
    ACTIMMUNE
    75473512 not registered Dead/Abandoned
    Legacy Health International, Inc.
    1998-04-24
    ACTIMMUNE
    ACTIMMUNE
    73796028 1617288 Live/Registered
    GENENTECH, INC.
    1989-04-26

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