Propranolol Hydrochloride
PROPRANOLOL HYDROCHLORIDE TABLETS, USPRx
Approved
Approval ID
c80a014b-64d6-833d-e053-2995a90a9d02
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 26, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
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 Code68071-2484
Application NumberANDA070322
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propranolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 26, 2021
FDA Product Classification
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB