FDA.reportPublic FDA data

Dantrolene Sodium

Product NDC
72162-2047
11-digit product format
721622047
Labeler code
72162
Product ID
72162-2047_1eb0bb7e-c81f-4609-8d2a-3ae24246fce8
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
100 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 SODIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii287M0347EV
Rxcui856652

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
72162-2047-1Dantrolene Sodium100 in 1 BOTTLECAPSULE100103
72162-2047-9Dantrolene Sodium90 in 1 BOTTLECAPSULE90103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2047-1EA - Each72162-2047ff3b4c38-f475-47a3-b7e7-febd44df76a712023-08-08
72162-2047-9EA - Each72162-2047ae51ec59-f73f-4c04-aec9-88d99b766d5b12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2047DANTROLENE SODIUM CAPSULE [BRYANT RANCH PREPACK]103Current NDC, 2 package rows20240821_e432a760-40b8-4efa-af2b-18e027ac5ae4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856652dantrolene sodium 100 MG Oral CapsulePSNe432a760-40b8-4efa-af2b-18e027ac5ae4103
856652dantrolene sodium 100 MG Oral CapsuleSCDe432a760-40b8-4efa-af2b-18e027ac5ae4103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2047-172162204701100 CAPSULE in 1 BOTTLE (72162-2047-1) 100 capsule2023-06-14NoNoCurrent
72162-2047-97216220470990 CAPSULE in 1 BOTTLE (72162-2047-9) 90 capsule2023-06-14NoNoCurrent