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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
287M0347EVDANTROLENE SODIUM24868-20-0DANTROLENE SODIUM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2047-172162204701100 CAPSULE in 1 BOTTLE (72162-2047-1) 100 capsule2023-06-14NoNoHistorical
72162-2047-97216220470990 CAPSULE in 1 BOTTLE (72162-2047-9) 90 capsule2023-06-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dantrolene Sodium CapsulesBryant Ranch Prepack2024-08-20HUMAN PRESCRIPTION DRUG LABEL103