PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride Extended-release Capsules, USP
Approved
Approval ID
5a7858eb-9d2d-44d9-9f81-c78ba3ce1815
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2022
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
Products 4
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 Code68382-163
Application NumberANDA090321
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROPRANOLOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2022
FDA Product Classification
INGREDIENTS (9)
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPRANOLOL HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-162
Application NumberANDA090321
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROPRANOLOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2022
FDA Product Classification
INGREDIENTS (9)
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPRANOLOL HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-161
Application NumberANDA090321
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROPRANOLOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2022
FDA Product Classification
INGREDIENTS (9)
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPRANOLOL HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-164
Application NumberANDA090321
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROPRANOLOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2022
FDA Product Classification
INGREDIENTS (8)
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 160 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT