dantrolene sodium
Dantrolene Sodium Capsules
Approved
Approval ID
c83daa7b-f2c6-418f-a242-fe2d8cad4081
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 3, 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.
dantrolene sodium
PRODUCT DETAILS
NDC Product Code72162-1497
Application NumberNDA017443
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateDecember 5, 2017
Generic Namedantrolene sodium
INGREDIENTS (10)
DANTROLENE SODIUMActive
Quantity: 25 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