IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE- ipratropium bromide and albuterol sulfate solution
The Ritedose Corporation

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Ipratropium Bromide and Albuterol Sulfate Solution 0.5 mg/3 mg per 3 mL

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution

0.5 mg/3 mg per 3 mL

30 x 3 mL Sterile Unit-Dose Vials.

Rx Only

FOR INHALATION USE ONLY

Principal Display Panel - Ipratropium Bromide and Albuterol Sulfate Inhalation Solution 0.5 mg/3 mg per 3 mL (AHP) 30 ct Brick Carton

NDC 60687- 405-83

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution

0.5 mg/3 mg per 3 mL

30 x 3 mL Sterile Unit-Dose Vials.

Rx Only

FOR INHALATION USE ONLY

Ipra-Alb 30 ct Singles Carton

Principal Display Panel - Ipratropium Bromide and Albuterol Sulfate Inhalation Solution 0.5 mg/3 mg per 3 mL (GSMS) 30 ct Brick Carton

NDC 60429-975-30

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution

0.5 mg/3 mg per 3 mL

Rx Only

30 x 3 mL Sterile Unit-Dose (1 pouch of 30 - 3 mL vials)

GSMS I-A 30ct Carton

Principal Display Panel - Ipratropium Bromide and Albuterol Sulfate Inhalation Solution 0.5 mg/3 mg per 3 mL (GSMS) 60 ct Brick Carton

NDC 60429-975-60

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution

0.5 mg/3 mg per 3 mL

Rx Only

60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 - 3 mL vials)

GSMS I-A 60ct Carton

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
ipratropium bromide and albuterol sulfate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65302-047
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	2.5 mg in 3 mL
IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)	IPRATROPIUM BROMIDE ANHYDROUS	0.5 mg in 3 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65302-047-01	30 in 1 CARTON	12/15/2018
1		1 in 1 POUCH
1		3 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202496	12/15/2018

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
ipratropium bromide and albuterol sulfate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65302-053
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	2.5 mg in 3 mL
IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)	IPRATROPIUM BROMIDE ANHYDROUS	0.5 mg in 3 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65302-053-60	60 in 1 CARTON	10/17/2017
1		2 in 1 POUCH
1		3 mL in 1 AMPULE; Type 0: Not a Combination Product
2	NDC:65302-053-30	30 in 1 CARTON	10/17/2017
2		1 in 1 POUCH
2		3 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202496	10/17/2017

Labeler - The Ritedose Corporation (837769546)

Name	Address	ID/FEI	Business Operations
Establishment
The Ritedose Corporation		837769546	analysis(65302-047, 65302-053) , manufacture(65302-047, 65302-053) , pack(65302-047, 65302-053) , label(65302-047, 65302-053)

Revised: 1/2020

Document Id: 9d49f1ff-409c-7eb8-e053-2a95a90a29b4

Set id: 9adb9fa3-610c-0edf-e053-2a95a90aed18

Version: 2

Effective Time: 20200129

The Ritedose Corporation