PROPRANOLOL HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE
Approved
Approval ID
7cd94137-98d5-4c59-9924-44fe2f78790d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 21, 2020
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
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 Code61919-808
Application NumberANDA078955
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROPRANOLOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2020
FDA Product Classification
INGREDIENTS (8)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT