NDC Code(s) : 62332-655-01, 62332-655-30, 62332-655-60
Packager : Alembic Pharmaceuticals Inc.

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Formoterol Fumarate Formoterol Fumarate SOLUTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:62332-655
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FORMOTEROL FUMARATE(UNII: W34SHF8J2K)
(FORMOTEROL - UNII:5ZZ84GCW8B) 		FORMOTEROL FUMARATE20 ug in 2 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62332-655-3030 in 1 CARTON 22/11/2021
1NDC:62332-655-011 in 1 POUCH
12 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:62332-655-6060 in 1 CARTON 22/11/2021
21 in 1 POUCH
22 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215078 11/22/2021

LABELER - Alembic Pharmaceuticals Inc.(079288842)

Establishment
Name Address ID/FEI Business Operations
Holopack Verpackungstechnik GmbH 343390324 MANUFACTURE(62332-655)

PRINCIPAL DISPLAY PANEL

Formoterol Fumarate Inhalation Solution  - Pouch Label:

formoterol-pouch-label
Formoterol Fumarate Inhalation Solution  - Carton Label - 30's Pack:

formoterol-pouch-label
Formoterol Fumarate Inhalation Solution  - Carton Label - 60's Pack:

formoterol-pouch-label