NDC Code(s) : 0093-6723-45, 0093-6723-73, 0093-6723-74
Packager : Teva Pharmaceuticals USA Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol Sulfate SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-6723
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IPRATROPIUM BROMIDE(UNII: J697UZ2A9J)
(IPRATROPIUM - UNII:GR88G0I6UL) 		IPRATROPIUM0.5 mg in 3 mL
ALBUTEROL SULFATE(UNII: 021SEF3731)
(ALBUTEROL - UNII:QF8SVZ843E) 		ALBUTEROL2.5 mg in 3 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-6723-736 in 1 CARTON 01/02/2008
1NDC:0093-6723-455 in 1 POUCH
13 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
2NDC:0093-6723-7412 in 1 CARTON 01/02/2008
25 in 1 POUCH
23 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 ANDA076724 01/02/2008

PRINCIPAL DISPLAY PANEL

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution 0.5 mg/3 mg, 6 Pouches of Five 3 mL Vials Each (30 Unit-Dose Vials) Carton, Part 1 of 2

PRINCIPAL DISPLAY PANEL

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution 0.5 mg/3 mg, 6 Pouches of Five 3 mL Vials Each (30 Unit-Dose Vials) Carton, Part 2 of 2