dantrolene sodium

Product NDC
63629-2168
11-digit product format
636292168
Labeler code
63629
Product ID
63629-2168_49679d9e-ee69-4b6d-b01d-3a2eda854b9f
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
63629-2168-1dantrolene sodium100 in 1 BOTTLECAPSULE100106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2168-1EA - Each63629-216870847a8d-0cb8-449f-8360-8a0128e8926612021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2168DANTROLENE SODIUM CAPSULE [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 1 package rows20240807_f6ce8871-f1a5-43ea-9250-1999fb69b835.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856656dantrolene sodium 25 MG Oral CapsulePSNf6ce8871-f1a5-43ea-9250-1999fb69b835106
856656dantrolene sodium 25 MG Oral CapsuleSCDf6ce8871-f1a5-43ea-9250-1999fb69b835106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2168-163629216801100 CAPSULE in 1 BOTTLE (63629-2168-1) 100 capsule2021-03-110000-00-00NoNoCurrent