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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0891
Application NumberANDA070218
Product Classification
M
Marketing Category
C73584
G
Generic Name
propranolol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 18, 2014
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0813
Application NumberANDA070217
Product Classification
M
Marketing Category
C73584
G
Generic Name
propranolol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 18, 2014
FDA Product Classification
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