Dantrolene Sodium

Product NDC
72162-2045
11-digit product format
721622045
Labeler code
72162
Product ID
72162-2045_57a49e45-2998-4eda-9eac-fe843ceeb892
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dantrolene sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076686
Marketing category
ANDA
Marketing start
2005-10-26
Substance
DANTROLENE SODIUM
Active strength
25 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dantrolene Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DANTROLENE SODIUM25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii287M0347EV
Rxcui856656

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
72162-2045-1Dantrolene Sodium100 in 1 BOTTLECAPSULE100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2045-1EA - Each72162-204535cfebcb-d449-46fc-aa86-674086481fd512023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2045DANTROLENE SODIUM CAPSULE [BRYANT RANCH PREPACK]102Current NDC, 1 package rows20240816_dbf78d48-71a6-4a9b-bf31-e710b78944f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856656dantrolene sodium 25 MG Oral CapsulePSNdbf78d48-71a6-4a9b-bf31-e710b78944f2102
856656dantrolene sodium 25 MG Oral CapsuleSCDdbf78d48-71a6-4a9b-bf31-e710b78944f2102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2045-172162204501100 CAPSULE in 1 BOTTLE (72162-2045-1) 100 capsule2023-06-14NoNoHistorical