Dantrium
Dantrium (dantrolene sodium) capsules
Approved
Approval ID
57b4eec1-49e1-432c-95ae-0fe36e32d64b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 1, 2018
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 3
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 Code42023-126
Application NumberNDA017443
Product Classification
M
Marketing Category
C73594
G
Generic Name
dantrolene sodium
Product Specifications
Route of AdministrationORAL
Effective DateApril 12, 2021
FDA Product Classification
INGREDIENTS (8)
DANTROLENE SODIUMActive
Quantity: 100 mg in 1 1
Code: 287M0347EV
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
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
dantrolene sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42023-125
Application NumberNDA017443
Product Classification
M
Marketing Category
C73594
G
Generic Name
dantrolene sodium
Product Specifications
Route of AdministrationORAL
Effective DateApril 12, 2021
FDA Product Classification
INGREDIENTS (8)
DANTROLENE SODIUMActive
Quantity: 50 mg in 1 1
Code: 287M0347EV
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
dantrolene sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42023-124
Application NumberNDA017443
Product Classification
M
Marketing Category
C73594
G
Generic Name
dantrolene sodium
Product Specifications
Route of AdministrationORAL
Effective DateApril 12, 2021
FDA Product Classification
INGREDIENTS (8)
DANTROLENE SODIUMActive
Quantity: 25 mg in 1 1
Code: 287M0347EV
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
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