FDA.reportPublic FDA data

Dantrium

Product NDC
42023-125
11-digit product format
420230125
Labeler code
42023
Product ID
42023-125_ae3211d2-bff5-47ba-a683-331c32499f62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dantrolene sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
NDA017443
Marketing category
NDA
Marketing start
2008-08-01
Marketing end
2022-02-28
Substance
DANTROLENE SODIUM
Active strength
50 mg/1
Pharmacologic classes
Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e1aa0c0-7e5b-41f6-80ca-71938bc3ba10Product name220170803
d7dbb6a6-7ce7-4878-a62c-772d63bc4c9fProduct name220141210
aa6a0d9e-0b39-aacf-4e4e-ce5e489de585Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-125-01Dantrium100 in 1 BOTTLECAPSULE10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-125-01EA - Each42023-1257478a952-23c4-49d0-a41f-0e6f4415c0ee12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
dantrolene sodiumACTIVE INGREDIENT287M0347EVDANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC]6
dantroleneACTIVE MOIETYF64QU97QCRDANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC]6
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8DANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC]6
GelatinINACTIVE INGREDIENT2G86QN327LDANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC]6
LactoseINACTIVE INGREDIENTJ2B2A4N98GDANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC]6
Magnesium StearateINACTIVE INGREDIENT70097M6I30DANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC]6
TalcINACTIVE INGREDIENT7SEV7J4R1UDANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC]6
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPDANTRIUM (DANTROLENE SODIUM) CAPSULE [JHP PHARMACEUTICALS LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-125DANTRIUM (DANTROLENE SODIUM) CAPSULE [ENDO USA, INC.]13Legacy NDC, 1 package rows20250112_57b4eec1-49e1-432c-95ae-0fe36e32d64b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856654Dantrium 100 MG Oral CapsulePSN57b4eec1-49e1-432c-95ae-0fe36e32d64b13
856658Dantrium 25 MG Oral CapsulePSN57b4eec1-49e1-432c-95ae-0fe36e32d64b13
856662Dantrium 50 MG Oral CapsulePSN57b4eec1-49e1-432c-95ae-0fe36e32d64b13
856652dantrolene sodium 100 MG Oral CapsulePSN57b4eec1-49e1-432c-95ae-0fe36e32d64b13
856656dantrolene sodium 25 MG Oral CapsulePSN57b4eec1-49e1-432c-95ae-0fe36e32d64b13
856660dantrolene sodium 50 MG Oral CapsulePSN57b4eec1-49e1-432c-95ae-0fe36e32d64b13
856654dantrolene sodium 100 MG Oral Capsule [Dantrium]SBD57b4eec1-49e1-432c-95ae-0fe36e32d64b13
856658dantrolene sodium 25 MG Oral Capsule [Dantrium]SBD57b4eec1-49e1-432c-95ae-0fe36e32d64b13
856662dantrolene sodium 50 MG Oral Capsule [Dantrium]SBD57b4eec1-49e1-432c-95ae-0fe36e32d64b13
856652dantrolene sodium 100 MG Oral CapsuleSCD57b4eec1-49e1-432c-95ae-0fe36e32d64b13
856656dantrolene sodium 25 MG Oral CapsuleSCD57b4eec1-49e1-432c-95ae-0fe36e32d64b13
856660dantrolene sodium 50 MG Oral CapsuleSCD57b4eec1-49e1-432c-95ae-0fe36e32d64b13
856654Dantrium 100 MG Oral CapsuleSY57b4eec1-49e1-432c-95ae-0fe36e32d64b13
856658Dantrium 25 MG Oral CapsuleSY57b4eec1-49e1-432c-95ae-0fe36e32d64b13
856662Dantrium 50 MG Oral CapsuleSY57b4eec1-49e1-432c-95ae-0fe36e32d64b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42023-125-0142023012501100 CAPSULE in 1 BOTTLE (42023-125-01) 100 capsule2008-08-010000-00-00NoNoCurrent