Propranolol Hydrochloride
Rx Only
Approved
Approval ID
b756f602-62c9-41ef-a934-834ac81b46ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2023
Manufacturers
FDA
Nortec Development Associates, Inc
DUNS: 131801359
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 Code42689-011
Application NumberANDA078065
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propranolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2023
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
ETHYLCELLULOSE (45 MPA.S)Inactive
Code: V7AD894FAZ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Propranolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42689-014
Application NumberANDA078065
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propranolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2023
FDA Product Classification
INGREDIENTS (8)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
ETHYLCELLULOSE (45 MPA.S)Inactive
Code: V7AD894FAZ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 160 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
Propranolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42689-013
Application NumberANDA078065
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propranolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2023
FDA Product Classification
INGREDIENTS (8)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
ETHYLCELLULOSE (45 MPA.S)Inactive
Code: V7AD894FAZ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
Propranolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42689-012
Application NumberANDA078065
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propranolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2023
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
ETHYLCELLULOSE (45 MPA.S)Inactive
Code: V7AD894FAZ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB