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 ID: 75987-111_10c38fa8-bbf3-40e5-83dc-bc105723a442
• NDC: 75987-111
• Product Type: Human Prescription Drug
• Proprietary Name: ACTIMMUNE
• Generic Name: Interferon Gamma-1b
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2013-12-01
• Marketing Category: BLA / BLA
• Application Number: BLA103836
• Labeler Name: Horizon Therapeutics USA, Inc.
• Substance Name: INTERFERON GAMMA-1B
• Active Ingredient Strength: 100 ug/.5mL
• Pharm Classes: Interferon gamma [EPC],Interferon-gamma [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

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 Date: 2013-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 75987-111-10 [75987011110]

ACTIMMUNE INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103836
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-12-01

NDC 75987-111-11 [75987011111]

ACTIMMUNE INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103836
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-12-01

Drug Details

Active Ingredients

Ingredient	Strength
INTERFERON GAMMA-1B	100 ug/.5mL

OpenFDA Data

• SPL SET ID: 5d0b1256-1981-4519-94f4-a4a2f98bd8a3
• Manufacturer:
  • Horizon Pharma Inc.
• UNII:
  • 21K6M2I7AG
• 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"

NDC	Brand Name	Generic Name
75987-111	ACTIMMUNE	Interferon gamma-1b
17089-378	GUNA-INF GAMMA	INTERFERON GAMMA-1B