NDC Code(s) : 72162-1880-6
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DronabinolDronabinol CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72162-1880(NDC:67877-755)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DRONABINOL(UNII: 7J8897W37S)
(DRONABINOL - UNII:7J8897W37S) 		DRONABINOL10 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
SESAME OIL(UNII: QX10HYY4QV)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color ORANGE (ORANGE) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code MX
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72162-1880-660 in 1 BOTTLE Type 0: Not a Combination Product30/03/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA018651 03/03/2021

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(72162-1880), RELABEL(72162-1880)

PRINCIPAL DISPLAY PANEL

Dronabinol 10 mg Capsule #60

Label