Propranolol HCL ER
Propranolol hcl ER 60mg
Approved
Approval ID
5c370417-eff0-7280-e053-2a91aa0a1446
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 19, 2019
Manufacturers
FDA
Direct Rx
DUNS: 079254320
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Propranolol hcl ER
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-488
Application NumberNDA018553
Product Classification
M
Marketing Category
C73605
G
Generic Name
Propranolol hcl ER
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2019
FDA Product Classification
INGREDIENTS (6)
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ETHYLCELLULOSE (100 MPA.S)Inactive
Code: 47MLB0F1MV
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Propranolol HCL ER
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-794
Application NumberANDA078703
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propranolol HCL ER
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2019
FDA Product Classification
INGREDIENTS (13)
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKR
Classification: IACT
PROPRANOLOL HYDROCHLORIDE ER
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-489
Application NumberNDA018553
Product Classification
M
Marketing Category
C73605
G
Generic Name
PROPRANOLOL HYDROCHLORIDE ER
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2019
FDA Product Classification
INGREDIENTS (8)
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
ETHYLCELLULOSE (100 MPA.S)Inactive
Code: 47MLB0F1MV
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT