Ipratropium Bromide and Albuterol Sulfate
Ipratropium Bromide and Albuterol Sulfate
Approved
Approval ID
001e3b1c-b7c1-44aa-b812-e78dbf4f3069
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2017
Manufacturers
FDA
Medical Supply Distribution, Llc.
DUNS: 080470358
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ipratropium Bromide and Albuterol Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71152-201
Application NumberANDA076749
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ipratropium Bromide and Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 22, 2017
FDA Product Classification
INGREDIENTS (5)
IPRATROPIUM BROMIDEActive
Quantity: 0.5 mg in 3 mL
Code: J697UZ2A9J
Classification: ACTIR
ALBUTEROL SULFATEActive
Quantity: 3 mg in 3 mL
Code: 021SEF3731
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT