Propranolol Hydrochloride
PROPRANOLOL HYDROCHLORIDE TABLETS, USPRx
Approved
Approval ID
8efc9fc6-6db0-43c9-892b-7423a9ba679f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2023
Manufacturers
FDA
AMICI PHARMACEUTICALS LLC
DUNS: 079536824
Products 5
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 Code69292-538
Application NumberANDA070322
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propranolol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2019
FDA Product Classification
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Propranolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69292-530
Application NumberANDA070322
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propranolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2019
FDA Product Classification
INGREDIENTS (7)
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Propranolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69292-534
Application NumberANDA070322
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propranolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2019
FDA Product Classification
INGREDIENTS (8)
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
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 Code69292-536
Application NumberANDA070322
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propranolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2019
FDA Product Classification
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
Propranolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69292-532
Application NumberANDA070322
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propranolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2019
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT