FDA.reportPublic FDA data

Dantrium

Product NDC
42023-123
11-digit product format
420230123
Labeler code
42023
Product ID
42023-123_dd4a56ce-80e3-4794-94a8-cb2b14695b89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dantrolene sodium
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Par Health USA, LLC
Application
NDA018264
Marketing category
NDA
Marketing start
2009-04-20
Substance
DANTROLENE SODIUM
Active strength
20 mg/60mL
Pharmacologic classes
Decreased Striated Muscle Contraction [PE], Decreased Striated Muscle Tone [PE], Skeletal Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dantrium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DANTROLENE SODIUM20 mg/60mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii287M0347EV
Rxcui856696, 856698

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0e1aa0c0-7e5b-41f6-80ca-71938bc3ba10Product name220170803
d7dbb6a6-7ce7-4878-a62c-772d63bc4c9fProduct name220141210
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
aa6a0d9e-0b39-aacf-4e4e-ce5e489de585Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-123-06Dantrium60 mL in 1 VIALINJECTION6015
42023-123-06Dantrium6 in 1 CARTONINJECTION615

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-123-06EA - Each42023-1230613ff7c-1443-419d-9c3b-823ee26cb68b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
dantrolene sodiumACTIVE INGREDIENT287M0347EVDANTRIUM (DANTROLENE SODIUM) INJECTION [PAR PHARMACEUTICAL, INC.]5
dantroleneACTIVE MOIETYF64QU97QCRDANTRIUM (DANTROLENE SODIUM) INJECTION [PAR PHARMACEUTICAL, INC.]5
mannitolINACTIVE INGREDIENT3OWL53L36ADANTRIUM (DANTROLENE SODIUM) INJECTION [PAR PHARMACEUTICAL, INC.]5
sodium hydroxideINACTIVE INGREDIENT55X04QC32IDANTRIUM (DANTROLENE SODIUM) INJECTION [PAR PHARMACEUTICAL, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-123DANTRIUM (DANTROLENE SODIUM) INJECTION [ENDO USA, INC.]12Current NDC, Legacy NDC, 2 package rows20240709_4df35098-8702-46be-ac67-30cfdf1aa570.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856698Dantrium 0.333 MG/ML Injectable SolutionPSN4df35098-8702-46be-ac67-30cfdf1aa57015
856696dantrolene sodium 0.333 MG/ML Injectable SolutionPSN4df35098-8702-46be-ac67-30cfdf1aa57015
856698dantrolene sodium 0.333 MG/ML Injectable Solution [Dantrium]SBD4df35098-8702-46be-ac67-30cfdf1aa57015
856696dantrolene sodium 0.333 MG/ML Injectable SolutionSCD4df35098-8702-46be-ac67-30cfdf1aa57015
856698Dantrium 0.333 MG/ML (as dantrolene sodium) Injectable SolutionSY4df35098-8702-46be-ac67-30cfdf1aa57015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42023-123-06420230123066 VIAL in 1 CARTON (42023-123-06) / 60 mL in 1 VIAL6 vial2009-04-200000-00-00NoNoCurrent