Propranolol Hydrochloride
Approved
Approval ID
ee09b4db-4d28-4748-a471-0f7b8c491f54
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 26, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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
NDC Product Code54868-0696
Application NumberANDA078955
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 26, 2010
Generic NamePropranolol Hydrochloride
INGREDIENTS (8)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 80 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Propranolol Hydrochloride
PRODUCT DETAILS
NDC Product Code54868-0052
Application NumberANDA078955
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 26, 2010
Generic NamePropranolol Hydrochloride
INGREDIENTS (8)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Propranolol Hydrochloride
PRODUCT DETAILS
NDC Product Code54868-0293
Application NumberANDA078955
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 26, 2010
Generic NamePropranolol Hydrochloride
INGREDIENTS (7)
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Propranolol Hydrochloride
PRODUCT DETAILS
NDC Product Code54868-0053
Application NumberANDA078955
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 26, 2010
Generic NamePropranolol Hydrochloride
INGREDIENTS (9)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Propranolol Hydrochloride
PRODUCT DETAILS
NDC Product Code54868-5564
Application NumberANDA078955
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 26, 2010
Generic NamePropranolol Hydrochloride
INGREDIENTS (7)
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT