actimmune

Generic: interferon gamma-1b

Labeler: horizon therapeutics usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name actimmune
Generic Name interferon gamma-1b
Labeler horizon therapeutics usa, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

interferon gamma-1b 100 ug/.5mL

Manufacturer
Horizon Therapeutics USA, Inc.

Identifiers & Regulatory

Product NDC 75987-111
Product ID 75987-111_845065f7-20e0-41bb-baee-00004b71c5d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103836
Listing Expiration 2026-12-31
Marketing Start 2013-12-01

Pharmacologic Class

Established (EPC)
interferon gamma [epc]
Chemical Structure
interferon-gamma [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75987111
Hyphenated Format 75987-111

Supplemental Identifiers

RxCUI
240448 751970
UNII
21K6M2I7AG
NUI
N0000175541 M0011490

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name actimmune (source: ndc)
Generic Name interferon gamma-1b (source: ndc)
Application Number BLA103836 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/.5mL
source: ndc
Packaging
  • 12 VIAL, SINGLE-DOSE in 1 CARTON (75987-111-11) / .5 mL in 1 VIAL, SINGLE-DOSE (75987-111-10)
source: ndc

Packages (1)

75987-111-11 12 VIAL, SINGLE-DOSE in 1 CARTON (75987-111-11) / .5 mL in 1 VIAL, SINGLE-DOSE (75987-111-10)

Ingredients (1)

interferon gamma-1b (100 ug/.5mL)

Linked Drug Pages (1)

ACTIMMUNE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "845065f7-20e0-41bb-baee-00004b71c5d2", "openfda": {"nui": ["N0000175541", "M0011490"], "unii": ["21K6M2I7AG"], "rxcui": ["240448", "751970"], "spl_set_id": ["5d0b1256-1981-4519-94f4-a4a2f98bd8a3"], "pharm_class_cs": ["Interferon-gamma [CS]"], "pharm_class_epc": ["Interferon gamma [EPC]"], "manufacturer_name": ["Horizon Therapeutics USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 VIAL, SINGLE-DOSE in 1 CARTON (75987-111-11)  / .5 mL in 1 VIAL, SINGLE-DOSE (75987-111-10)", "package_ndc": "75987-111-11", "marketing_start_date": "20131201"}], "brand_name": "ACTIMMUNE", "product_id": "75987-111_845065f7-20e0-41bb-baee-00004b71c5d2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Interferon gamma [EPC]", "Interferon-gamma [CS]"], "product_ndc": "75987-111", "generic_name": "Interferon gamma-1b", "labeler_name": "Horizon Therapeutics USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ACTIMMUNE", "active_ingredients": [{"name": "INTERFERON GAMMA-1B", "strength": "100 ug/.5mL"}], "application_number": "BLA103836", "marketing_category": "BLA", "marketing_start_date": "20131201", "listing_expiration_date": "20261231"}