Ipratropium Bromide (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — RDP 30 ct Singles Carton

NDC 76204-100-01

Ipratropium Bromide Inhalation Solution, 0.02%
0.5 mg / 2.5 mL

FOR ORAL INHALATION ONLY

INGREDIENTS: Each low density polyethylene vial contains: 2.5 mL Ipratropium Bromide 0.02%, preservative free, isotonic sterile aqueous solution containing sodium chloride. Adjusted to pH 3.4 (3 to 4) with hydrochloric acid.
Usual Dosage: See accompanying prescribing information.
Store between 15° and 30°C (59° and 86°F). Protect from light. ATTENTION PHARMACIST: Detach “Patient’s Instructions For Use” from package insert and dispense with solution.

Rx Only

30 x 2.5 mL Sterile Unit-Dose Vials, each in a foil pouch

30 ct singles carton
(click image for full-size original)
IPRATROPIUM BROMIDE ipratropium bromide solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76204-100
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IPRATROPIUM BROMIDE (IPRATROPIUM) IPRATROPIUM BROMIDE ANHYDROUS 0.5 mg in 2.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76204-100-25 1 POUCH in 1 CARTON contains a POUCH
1 25 AMPULE in 1 POUCH This package is contained within the CARTON (76204-100-25) and contains a AMPULE
1 2.5 mL in 1 AMPULE This package is contained within a POUCH and a CARTON (76204-100-25)
2 NDC:76204-100-30 1 POUCH in 1 CARTON contains a POUCH
2 30 AMPULE in 1 POUCH This package is contained within the CARTON (76204-100-30) and contains a AMPULE
2 2.5 mL in 1 AMPULE This package is contained within a POUCH and a CARTON (76204-100-30)
3 NDC:76204-100-60 2 POUCH in 1 CARTON contains a POUCH
3 30 AMPULE in 1 POUCH This package is contained within the CARTON (76204-100-60) and contains a AMPULE
3 2.5 mL in 1 AMPULE This package is contained within a POUCH and a CARTON (76204-100-60)
4 NDC:76204-100-01 30 POUCH in 1 CARTON contains a POUCH
4 1 AMPULE in 1 POUCH This package is contained within the CARTON (76204-100-01) and contains a AMPULE
4 2.5 mL in 1 AMPULE This package is contained within a POUCH and a CARTON (76204-100-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075693 02/01/2011
Labeler — Ritedose Pharmaceuticals, LLC (968062294)

Revised: 12/2021 Ritedose Pharmaceuticals, LLC

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