FDA.reportPublic FDA data

SYNDROS

Product NDC
20482-335
11-digit product format
204820335
Labeler code
20482
Product ID
20482-335_7bcc893e-abb1-48e3-a804-d41554d2a92f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dronabinol
Dosage form
SOLUTION
Route
ORAL
Labeler
Insys Therapeutics, Inc.
Application
NDA205525
Marketing category
NDA
Marketing start
2017-07-27
Marketing end
0000-00-00
Substance
DRONABINOL
Active strength
5 mg/mL
Pharmacologic classes
Cannabinoid [EPC],Cannabinoids [CS]
DEA schedule
CII
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
a078d9db-810e-ade7-7f79-e8c1623628f9Product name420200617
03fbef77-e64f-4d6b-9d24-bfd1671e5179Product name120190402

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
20482-335-302020-09-27C16284748780-1ab0e2407-314b-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use SYNDROS safely and effectively. See full prescribing information for SYNDROS. SYNDROS ® (dronabinol) oral solution, CII Initial U.S. Approval: 1985
20482-335-302020-09-25C16284748780-1ab0e2407-314b-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use SYNDROS safely and effectively. See full prescribing information for SYNDROS. SYNDROS ® (dronabinol) oral solution, CII Initial U.S. Approval: 1985
20482-335-302020-07-22C16284748780-1ab0e2407-314b-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use SYNDROS safely and effectively. See full prescribing information for SYNDROS. SYNDROS ® (dronabinol) oral solution, CII Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
20482-335-30SYNDROS1 in 1 CARTONSOLUTION112
20482-335-30SYNDROS30 mL in 1 BOTTLE, GLASSSOLUTION3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
20482-335-30ML - Milliliter20482-335883fd777-f38d-4a8e-afd7-9d8441a5d6f812017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
20482-335SYNDROS (DRONABINOL) SOLUTION [INSYS THERAPEUTICS, INC.]12Legacy NDC, 2 package rows20191214_c2bc83c1-f9fe-11e2-b778-0800200c9a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1928948droNABinol 5 MG/mL Oral SolutionPSNc2bc83c1-f9fe-11e2-b778-0800200c9a6612
1928954SYNDROS 5 MG/mL Oral SolutionPSNc2bc83c1-f9fe-11e2-b778-0800200c9a6612
1928954dronabinol 5 MG/ML Oral Solution [Syndros]SBDc2bc83c1-f9fe-11e2-b778-0800200c9a6612
1928948dronabinol 5 MG/ML Oral SolutionSCDc2bc83c1-f9fe-11e2-b778-0800200c9a6612
1928948dronabinol 5 MG/ML Oral SolutionSYc2bc83c1-f9fe-11e2-b778-0800200c9a6612
1928954Syndros 5 MG/ML Oral SolutionSYc2bc83c1-f9fe-11e2-b778-0800200c9a6612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
20482-335-30204820335301 in 1 CARTONHistorical