FDA.reportPublic FDA data

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
IngredientStrength
INTERFERON GAMMA-1B100 ug/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii21K6M2I7AG
Rxcui240448, 751970

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d45267e3-883a-4760-85b5-ebc565c21683Product name120150910

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75987-111-10ACTIMMUNE0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION0.511
75987-111-11ACTIMMUNE12 in 1 CARTONINJECTION, SOLUTION1211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75987-111-10ML - Milliliter75987-1110e9c0206-e54e-4e9b-880e-d5bc0cb8a20612018-02-20
75987-111-11ML - Milliliter75987-1117bd15e43-c77e-4665-841d-1c6a9c23a9c112018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75987-111ACTIMMUNE (INTERFERON GAMMA-1B) INJECTION, SOLUTION [HORIZON THERAPEUTICS USA, INC.]9Current NDC, Legacy NDC, 2 package rows20250501_5d0b1256-1981-4519-94f4-a4a2f98bd8a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751970ACTIMMUNE 100 MCG in 0.5 ML InjectionPSN5d0b1256-1981-4519-94f4-a4a2f98bd8a311
240448interferon gamma-1b 100 MCG in 0.5 ML InjectionPSN5d0b1256-1981-4519-94f4-a4a2f98bd8a311
7519700.5 ML interferon gamma-1b 0.2 MG/ML Injection [Actimmune]SBD5d0b1256-1981-4519-94f4-a4a2f98bd8a311
2404480.5 ML interferon gamma-1b 0.2 MG/ML InjectionSCD5d0b1256-1981-4519-94f4-a4a2f98bd8a311
751970Actimmune 0.1 MG per 0.5 ML InjectionSY5d0b1256-1981-4519-94f4-a4a2f98bd8a311
751970Actimmune 100 MCG per 0.5 ML InjectionSY5d0b1256-1981-4519-94f4-a4a2f98bd8a311
751970Actimmune 2,000,000 UNT per 0.5 ML InjectionSY5d0b1256-1981-4519-94f4-a4a2f98bd8a311
240448interferon gamma-1b 0.1 MG per 0.5 ML InjectionSY5d0b1256-1981-4519-94f4-a4a2f98bd8a311
240448interferon gamma-1b 100 MCG per 0.5 ML InjectionSY5d0b1256-1981-4519-94f4-a4a2f98bd8a311
240448interferon gamma-1b 2,000,000 UNT per 0.5 ML InjectionSY5d0b1256-1981-4519-94f4-a4a2f98bd8a311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75987-111-10759870111100.5 mL in 1 VIAL, SINGLE-DOSE0.5 mlHistorical
75987-111-117598701111112 VIAL, SINGLE-DOSE in 1 CARTON (75987-111-11) / .5 mL in 1 VIAL, SINGLE-DOSE (75987-111-10) 2013-12-010000-00-00NoNoCurrent