Propranolol Hydrochloride
Approved
Approval ID
7da9bb37-cc22-4eff-8de0-429f64cb599e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 22, 2016
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
propranolol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-961
Application NumberANDA070213
Product Classification
M
Marketing Category
C73584
G
Generic Name
propranolol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 19, 2014
FDA Product Classification
INGREDIENTS (8)
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
propranolol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-084
Application NumberANDA070213
Product Classification
M
Marketing Category
C73584
G
Generic Name
propranolol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 19, 2014
FDA Product Classification
INGREDIENTS (10)
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT