Dronabinol

Product NDC
49884-868
11-digit product format
498840868
Labeler code
49884
Product ID
49884-868_8e792359-de7f-4875-9834-0d74bd6066ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dronabinol
Dosage form
CAPSULE
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA078292
Marketing category
ANDA
Marketing start
2008-06-27
Marketing end
0000-00-00
Substance
DRONABINOL
Active strength
5 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
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
49884-868-02EA - Each49884-868c914510f-a7bf-4cdd-913e-25956472377d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DRONABINOLACTIVE INGREDIENT7J8897W37SDRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
DRONABINOLACTIVE MOIETY7J8897W37SDRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XDRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LDRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
SESAME OILINACTIVE INGREDIENTQX10HYY4QVDRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71ODRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RDRONABINOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197636droNABinol 5 MG Oral CapsulePSN5050ed63-c6bc-4761-9a81-ef8e5f3f378e3
197636dronabinol 5 MG Oral CapsuleSCD5050ed63-c6bc-4761-9a81-ef8e5f3f378e3
197636dronabinol 5 MG Oral CapsuleSY5050ed63-c6bc-4761-9a81-ef8e5f3f378e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-868-0149884086801100 CAPSULE in 1 BOTTLE (49884-868-01) 100 capsule2008-06-270000-00-00NoNoCurrent
49884-868-0549884086805500 CAPSULE in 1 BOTTLE (49884-868-05) 500 capsule2008-06-270000-00-00NoNoCurrent
49884-868-154988408681525 CAPSULE in 1 BOTTLE (49884-868-15) 25 capsule2008-06-270000-00-00NoNoCurrent