dantrolene sodium

Product NDC
72162-1497
11-digit product format
721621497
Labeler code
72162
Product ID
72162-1497_9974d620-d55a-44ec-9202-fe552286d921
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dantrolene sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA017443
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-03-28
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
72162-1497-1dantrolene sodium100 in 1 BOTTLECAPSULE100100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1497-1EA - Each72162-1497a0ecd69b-8f05-4dab-97b1-6ac477fb5bfc12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1497DANTROLENE SODIUM CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20231004_c83daa7b-f2c6-418f-a242-fe2d8cad4081.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856656dantrolene sodium 25 MG Oral CapsulePSNc83daa7b-f2c6-418f-a242-fe2d8cad4081100
856656dantrolene sodium 25 MG Oral CapsuleSCDc83daa7b-f2c6-418f-a242-fe2d8cad4081100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1497-172162149701100 CAPSULE in 1 BOTTLE (72162-1497-1) 100 capsule2023-10-03NoNoCurrent