FDA.reportPublic FDA data

Dantrolene Sodium

Product NDC
50268-217
11-digit product format
502680217
Labeler code
50268
Product ID
50268-217_32f9f951-bf56-47f2-e063-6394a90a9c6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dantrolene Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA076856
Marketing category
ANDA
Marketing start
2021-03-09
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
50268-217-11Dantrolene Sodium1 in 1 BLISTER PACKCAPSULE15
50268-217-15Dantrolene Sodium50 in 1 BOXCAPSULE505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-217-11EA - Each50268-217462b2fed-3936-4732-b7c6-4bae7830bf9a12021-04-08
50268-217-15EA - Each50268-2171022667a-ab2f-4a51-9187-adb94385e0b612021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-217DANTROLENE SODIUM CAPSULE [AVPAK]5Current NDC, Legacy NDC, 2 package rows20250418_bd1ef298-2219-2a01-e053-2995a90abb08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856656dantrolene sodium 25 MG Oral CapsulePSNbd1ef298-2219-2a01-e053-2995a90abb085
856656dantrolene sodium 25 MG Oral CapsuleSCDbd1ef298-2219-2a01-e053-2995a90abb085

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-217-11502680217111 in 1 BLISTER PACKHistorical
50268-217-155026802171550 BLISTER PACK in 1 BOX (50268-217-15) / 1 CAPSULE in 1 BLISTER PACK (50268-217-11) 50 blister pack2021-03-090000-00-00NoNoCurrent