NDC Code(s) : 69097-168-48, 69097-168-87, 69097-168-64, 69097-168-32, 69097-168-53
Packager : Cipla USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

arformoterol tartrate arformoterol tartrate SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-168
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARFORMOTEROL TARTRATE(UNII: 5P8VJ2I235)
(ARFORMOTEROL - UNII:F91H02EBWT) 		ARFORMOTEROL15 ug in 2 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-168-876 in 1 CARTON 22/06/2021
1NDC:69097-168-485 in 1 POUCH
12 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
2NDC:69097-168-6412 in 1 CARTON 22/06/2021
25 in 1 POUCH
22 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
3NDC:69097-168-5330 in 1 CARTON 27/01/2022
3NDC:69097-168-321 in 1 POUCH
32 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207306 06/22/2021

LABELER - Cipla USA Inc.(078719707)

REGISTRANT - Cipla USA Inc.(078719707)

Establishment
Name Address ID/FEI Business Operations
Cipla Limited- Kurkumbh 917066446 API MANUFACTURE(69097-168)

Establishment
Name Address ID/FEI Business Operations
Cipla Ltd. Indore 918596409 ANALYSIS(69097-168), MANUFACTURE(69097-168), LABEL(69097-168), PACK(69097-168)

PRINCIPAL DISPLAY PANEL

NDC 69097-168-48 Rx Only

Arformoterol

Tartrate

Inhalation Solution

15mcg/2ml

*Potency expressed as arformoterol

Keep out of reach of children.

After opening the foil pouch, the

unused vials should be returned

to, and stored in, the pouch.

One unit-dose vial is one dose

5 X 2 mL Sterile Unit-Dose Vials

Cipla

5s foil

NDC 69097-168-64 Rx Only

Arformoterol Tartrate

Inhalation Solution

15mcg*/2mL

*Potency expressed as arformoterol

For Oral Inhalation Only.

KEEP REFRIGERATED OR STORE AT ROOM TEMPERATURE FOR UP TO 6 WEEKS

6 0 (12 x 5) x 2 mL Sterile Unit- Dose Vials

Cipla

5s foil

NDC 69097-168-87 Rx Only

Arformoterol Tartrate

Inhalation Solution

15mcg*/2mL

*Potency expressed as arformoterol

For Oral Inhalation Only.

KEEP REFRIGERATED OR STORE AT ROOM TEMPERATURE FOR UP TO 6 WEEKS

30 (6 x 5) x 2 mL Sterile Unit- Dose Vials

Cipla

5s foil

NDC 69097-168-32               Rx Only

Arformoterol Tartrate

Inhalation Solution

15 mcg* / 2 mL

Potency expressed as arformoterol

One 2 mL Sterile Unit-Dose Vial

 

Cipla

5s foil

NDC 69097-168-53                 Rx Only

 

*Potency expressed as arformoterol

15 mcg* / 2 mL

For Oral Inhalation Only.

KEEP REFRIGERATED OR STORE AT ROOM TEMPERATURE

FOR UP TO 6 WEEKS

30 x 2 mL Sterile Unit-Dose Vials, each in a foil pouch.

Cipla

5s foil