dantrolene sodium

Product NDC
63629-2170
11-digit product format
636292170
Labeler code
63629
Product ID
63629-2170_353b57e7-8fa2-4317-a9b5-e49b123a485c
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
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2170-1EA - Each63629-2170e54fe3ee-5768-4b6b-b5a4-bbf2e149461312021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2170DANTROLENE SODIUM CAPSULE [BRYANT RANCH PREPACK]102Legacy NDC20240112_11850cd6-da36-4d83-b385-0abd3122ed96.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2170-163629217001100 CAPSULE in 1 BOTTLE (63629-2170-1) 100 capsule2021-03-120000-00-00NoNoCurrent