Propranolol Hydrochloride
PROPRANOLOL HYDROCHLORIDE TABLETS USP Rx only
Approved
Approval ID
813dbecc-e5d4-4713-950f-c81d82120520
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2014
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
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
NDC Product Code53808-0891
Application NumberANDA070218
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 18, 2014
Generic Namepropranolol hydrochloride
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
propranolol hydrochloride
PRODUCT DETAILS
NDC Product Code53808-0813
Application NumberANDA070217
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 18, 2014
Generic Namepropranolol hydrochloride
INGREDIENTS (8)
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT