H.P. Acthar (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 5 mL Vial Carton

NDC 63004-8710-1

H.P.* Acthar ®
Gel

(repository corticotropin
injection)

400 USP units/5 mL
(80 USP units/mL)

For intramuscular or
subcutaneous use.

5 mL
multiple-dose vial

Dispense the enclosed
Medication Guide to each
Infantile Spasm patient.

Rx only*HIGHLY PURIFIED

PRINCIPAL DISPLAY PANEL -- 5 mL Vial Carton
(click image for full-size original)
H.P. ACTHAR repository corticotropin injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63004-8710
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORTICOTROPIN (CORTICOTROPIN) CORTICOTROPIN 80 [USP'U] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED
PHENOL
CYSTEINE
SODIUM HYDROXIDE
ACETIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63004-8710-1 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (63004-8710-1)
2 NDC:63004-8710-2 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
2 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (63004-8710-2)
3 NDC:63004-8710-3 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
3 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (63004-8710-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022432 01/07/2013
Labeler — Mallinckrodt ARD Inc. (625130828)
Establishment
Name Address ID/FEI Operations
Cangene bioPharma Inc. 050783398 MANUFACTURE (63004-8710)

Revised: 05/2018 Mallinckrodt ARD Inc.

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