Home NDC 75987-111 ACTIMMUNE
Product NDC 75987-111
11-digit product format 759870111
Labeler code 75987
Product ID 75987-111_8d803fd6-c715-4d8b-818b-bd5d537c3d60
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Interferon gamma-1b
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Horizon Therapeutics USA, Inc.
Application BLA103836
Marketing category BLA
Marketing start 2013-12-01
Substance INTERFERON GAMMA-1B
Active strength 100 ug/.5mL
Pharmacologic classes Interferon gamma [EPC], Interferon-gamma [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base ACTIMMUNE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INTERFERON GAMMA-1B 100 ug/.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 21K6M2I7AG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 240448 Internal RxNorm lookup 751970 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75987-111-10 ACTIMMUNE 0.5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 0.5 11 75987-111-11 ACTIMMUNE 12 in 1 CARTON INJECTION, SOLUTION 12 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75987-111 ACTIMMUNE (INTERFERON GAMMA-1B) INJECTION, SOLUTION [HORIZON THERAPEUTICS USA, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20250501_5d0b1256-1981-4519-94f4-a4a2f98bd8a3.zip
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 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103836 Actimmune interferon gamma-1b 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 75987-111-10 75987011110 0.5 mL in 1 VIAL, SINGLE-DOSE 0.5 ml Historical 75987-111-11 75987011111 12 VIAL, SINGLE-DOSE in 1 CARTON (75987-111-11) / .5 mL in 1 VIAL, SINGLE-DOSE (75987-111-10) 2013-12-01 0000-00-00 No No Current