Dronabinol

Product NDC: 17478-763
11-digit product format: 174780763
Labeler code: 17478
Product ID: 17478-763_2cc92791-29e4-497a-a09b-0786379e5b2c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dronabinol
Dosage form: CAPSULE
Route: ORAL
Labeler: Akorn
Application: ANDA079217
Marketing category: ANDA
Marketing start: 2014-06-20
Marketing end: 0000-00-00
Substance: DRONABINOL
Active strength: 10 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 concept	Relation	Version	Effective
a078d9db-810e-ade7-7f79-e8c1623628f9	Product name	4	20200617
03fbef77-e64f-4d6b-9d24-bfd1671e5179	Product name	1	20190402

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-763-06	2024-01-30	C162847	48780-1	1030e365-5b6f-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use DRONABINOL CAPSULES safely and effectively. See full prescribing information for DRONABINOL CAPSULES. DRONABINOL capsules, for oral use, CIII Initial U.S. Approval: 1985

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-763	DRONABINOL CAPSULE [AKORN]	6	Legacy NDC	20220710_a0409d82-a61e-4b9e-8717-ced299ccedb2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-763-06	17478076306	1 BOTTLE in 1 CARTON (17478-763-06) > 60 CAPSULE in 1 BOTTLE	1 bottle	2014-06-20	0000-00-00	No	No	Current