FDA.reportPublic FDA data

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 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
17478-763-062024-01-30C16284748780-11030e365-5b6f-111a-e063-dadaa90a10e2These 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-763-06EA - Each17478-763a2334ab4-d7aa-4647-bf04-84a240a31d7212015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DronabinolACTIVE INGREDIENT7J8897W37SDRONABINOL CAPSULE [AKORN, INC.]2
DronabinolACTIVE MOIETY7J8897W37SDRONABINOL CAPSULE [AKORN, INC.]2
ammoniaINACTIVE INGREDIENT5138Q19F1XDRONABINOL CAPSULE [AKORN, INC.]2
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3DRONABINOL CAPSULE [AKORN, INC.]2
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GDRONABINOL CAPSULE [AKORN, INC.]2
dimethiconeINACTIVE INGREDIENT92RU3N3Y1ODRONABINOL CAPSULE [AKORN, INC.]2
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBDDRONABINOL CAPSULE [AKORN, INC.]2
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOADRONABINOL CAPSULE [AKORN, INC.]2
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A8DRONABINOL CAPSULE [AKORN, INC.]2
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357DRONABINOL CAPSULE [AKORN, INC.]2
gelatinINACTIVE INGREDIENT2G86QN327LDRONABINOL CAPSULE [AKORN, INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXDRONABINOL CAPSULE [AKORN, INC.]2
isopropyl alcoholINACTIVE INGREDIENTND2M416302DRONABINOL CAPSULE [AKORN, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3DRONABINOL CAPSULE [AKORN, INC.]2
sesame oilINACTIVE INGREDIENTQX10HYY4QVDRONABINOL CAPSULE [AKORN, INC.]2
shellacINACTIVE INGREDIENT46N107B71ODRONABINOL CAPSULE [AKORN, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DRONABINOL CAPSULE [AKORN, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDRONABINOL CAPSULE [AKORN, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RDRONABINOL CAPSULE [AKORN, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-763DRONABINOL CAPSULE [AKORN]6Legacy NDC20220710_a0409d82-a61e-4b9e-8717-ced299ccedb2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-763-06174780763061 BOTTLE in 1 CARTON (17478-763-06) > 60 CAPSULE in 1 BOTTLE1 bottle2014-06-200000-00-00NoNoCurrent