DRONABINOL

Product NDC
42858-867
11-digit product format
428580867
Labeler code
42858
Product ID
42858-867_5467a1be-b888-4f7c-9a62-5faf6c977b05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DRONABINOL
Dosage form
CAPSULE
Route
ORAL
Labeler
Rhodes Pharmaceuticals L.P.
Application
ANDA078292
Marketing category
ANDA
Marketing start
2018-06-26
Marketing end
0000-00-00
Substance
DRONABINOL
Active strength
3 mg/1
Pharmacologic classes
Cannabinoid [EPC],Cannabinoids [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2020-12-31
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42858-867-06EA - Each42858-86787261d11-5eaa-4fd9-9299-1292a61a422612018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42858-867DRONABINOL CAPSULE [RHODES PHARMACEUTICALS L.P.]5Legacy NDC20230318_3c06ccda-4819-40f8-b2db-fa294bb8a2fa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42858-867-064285808670660 CAPSULE in 1 BOTTLE (42858-867-06) 60 capsule2018-06-260000-00-00NoNoCurrent