Dronabinol

Product NDC
63629-8861
11-digit product format
636298861
Labeler code
63629
Product ID
63629-8861_6ef82939-e6ef-4cfa-8084-1c468acc3d38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dronabinol
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA018651
Marketing category
NDA
Marketing start
2021-03-03
Marketing end
0000-00-00
Substance
DRONABINOL
Active strength
5 mg/1
Pharmacologic classes
Cannabinoid [EPC], Cannabinoids [CS]
DEA schedule
CIII
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
63629-8861-1EA - Each63629-8861130cdf44-3753-4049-a567-45aa14bcbab612021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8861DRONABINOL CAPSULE [BRYANT RANCH PREPACK]102Legacy NDC20230316_ad8c4bd7-2ab0-437d-a2dc-4714138ed691.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8861-16362988610160 CAPSULE in 1 BOTTLE (63629-8861-1) 60 capsule2021-09-300000-00-00NoNoCurrent