propranolol hydrochloride
Propranolol Hydrochloride Extended-Release Capsules, USP
Approved
Approval ID
0e185e88-cea2-4d01-8711-67317247fd25
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 20, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code63629-2069
Application NumberANDA078703
Product Classification
M
Marketing Category
C73584
G
Generic Name
propranolol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2020
FDA Product Classification
INGREDIENTS (15)
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PROPRANOLOL HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: F8A3652H1V
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKR
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT