DRONABINOL

Product NDC
0527-4125
11-digit product format
005274125
Labeler code
0527
Product ID
0527-4125_aac4561c-b9ba-4d3a-b86c-be120e4593dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dronabinol
Dosage form
CAPSULE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA207421
Marketing category
ANDA
Marketing start
2020-02-10
Substance
DRONABINOL
Active strength
2.5 mg/1
Pharmacologic classes
Cannabinoid [EPC], Cannabinoids [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a078d9db-810e-ade7-7f79-e8c1623628f9Product name420200617
03fbef77-e64f-4d6b-9d24-bfd1671e5179Product name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-4125-35DRONABINOL60 in 1 BOTTLECAPSULE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-4125DRONABINOL CAPSULE [LANNETT COMPANY, INC.]2Current NDC, Legacy NDC, 1 package rows20230929_c51d327b-51cc-408d-b0b3-fde5389294d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197635droNABinol 2.5 MG Oral CapsulePSNc51d327b-51cc-408d-b0b3-fde5389294d02
197635dronabinol 2.5 MG Oral CapsuleSCDc51d327b-51cc-408d-b0b3-fde5389294d02
197635dronabinol 2.5 MG Oral CapsuleSYc51d327b-51cc-408d-b0b3-fde5389294d02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-4125-350052741253560 CAPSULE in 1 BOTTLE (0527-4125-35) 60 capsule2020-02-100000-00-00NoNoCurrent