propranolol hydrochloride
Propranolol Hydrochloride Extended-Release Capsules, USP
Approved
Approval ID
753ab3cb-e7ee-424b-aa7d-195b5871a40e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
AvKARE
DUNS: 796560394
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 Code42291-523
Application NumberANDA078703
Product Classification
M
Marketing Category
C73584
G
Generic Name
propranolol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (15)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKR
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
propranolol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-522
Application NumberANDA078703
Product Classification
M
Marketing Category
C73584
G
Generic Name
propranolol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (13)
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKR
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
propranolol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-525
Application NumberANDA078703
Product Classification
M
Marketing Category
C73584
G
Generic Name
propranolol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (16)
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKR
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 160 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
propranolol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-524
Application NumberANDA078703
Product Classification
M
Marketing Category
C73584
G
Generic Name
propranolol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (15)
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKR
Classification: IACT