dantrolene sodium
Dantrolene Sodium Capsules
Approved
Approval ID
11850cd6-da36-4d83-b385-0abd3122ed96
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
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.
dantrolene sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-2170
Application NumberNDA017443
Product Classification
M
Marketing Category
C73605
G
Generic Name
dantrolene sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2017
FDA Product Classification
INGREDIENTS (10)
DANTROLENE SODIUMActive
Quantity: 100 mg in 1 1
Code: 287M0347EV
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT