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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50268-217
Application NumberANDA076856
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dantrolene Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
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