NDC Code(s) : 70748-261-01, 70748-261-30, 70748-261-60
Packager : Lupin 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 Item Code (Source) NDC:70748-261
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:70748-261-3030 in 1 CARTON 28/11/2022
11 in 1 POUCH
1NDC:70748-261-012 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:70748-261-6060 in 1 CARTON 28/11/2022
21 in 1 POUCH
2NDC:70748-261-012 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 ANDA215053 11/28/2022

LABELER - Lupin Pharmaceuticals, Inc.(089153071)

PRINCIPAL DISPLAY PANEL

Formoterol Fumarate Inhalation Solution

20 mcg/2 mL Vial

Rx Only

Sterile Unit Dose Vials

For Oral Inhalation Only.

Each 2 mL Vial Contains: 

ACTIVE: Formoterol fumarate, USP

INACTIVES: Citric acid, sodium citrate, sodium chloride, and water.

NDC 70748-261-01 - Pouch Label

Pouch Label

Formoterol Fumarate Inhalation Solution

20 mcg/2 mL Vial

Rx Only

Patient Information for Patient Enclosed

Sterile Unit Dose Vials - Individually Wrapped - For Oral Inhalation Only.

Each 2 mL Vial Contains: ACTIVE: Formoterol fumarate, USP

INACTIVES: Citric acid, sodium citrate, sodium chloride, and water.

NDC 70748-261-30

Carton contains: 30 individual wrapped 2 mL unit dose vials

Pouch Label