DRONABINOL

Product NDC
60687-386
11-digit product format
606870386
Labeler code
60687
Product ID
60687-386_ea3cf898-8169-9375-e053-2a95a90ac7d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DRONABINOL
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078292
Marketing category
ANDA
Marketing start
2018-08-09
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
a078d9db-810e-ade7-7f79-e8c1623628f9Product name420200617
03fbef77-e64f-4d6b-9d24-bfd1671e5179Product name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-386-11DRONABINOL1 in 1 BLISTER PACKCAPSULE18
60687-386-21DRONABINOL30 in 1 BOX, UNIT-DOSECAPSULE308
60687-386-94DRONABINOL20 in 1 CARTONCAPSULE208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-386DRONABINOL CAPSULE [AMERICAN HEALTH PACKAGING]8Legacy NDC, 3 package rows20250109_35e04467-d429-4fe8-a7d8-b9d8f8376b5b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-386-11606870386111 in 1 BLISTER PACKHistorical
60687-386-216068703862130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-386-21) > 1 CAPSULE in 1 BLISTER PACK (60687-386-11) 30 blister pack2018-08-090000-00-00NoNoCurrent
60687-386-946068703869420 in 1 CARTONHistorical