Dantrolene Sodium
Dantrolene Sodium Capsules, USP
Approved
Approval ID
bd1ef298-2219-2a01-e053-2995a90abb08
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
AvPAK
DUNS: 832926666
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 Code50268-217
Application NumberANDA076856
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 9, 2024
Generic NameDantrolene Sodium
INGREDIENTS (10)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
DANTROLENE SODIUMActive
Quantity: 25 mg in 1 1
Code: 287M0347EV
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT