NDC Code(s) : 0378-8170-91, 0378-8171-91, 0378-8172-91
Packager : Mylan Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DronabinolDronabinol CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8170
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dronabinol(UNII: 7J8897W37S)
(Dronabinol - UNII:7J8897W37S) 		Dronabinol2.5 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
glycerin(UNII: PDC6A3C0OX)
sesame oil(UNII: QX10HYY4QV)
titanium dioxide(UNII: 15FIX9V2JP)
propylene glycol(UNII: 6DC9Q167V3)
ferrosoferric oxide(UNII: XM0M87F357)
polyvinyl acetate phthalate(UNII: 58QVG85GW3)
water(UNII: 059QF0KO0R)
isopropyl alcohol(UNII: ND2M416302)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
ammonia(UNII: 5138Q19F1X)
Product Characteristics
Color WHITE (opaque off-white) Score no score
Shape CAPSULE (oval) Size 12 mm
Flavor Imprint Code INS
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-8170-9160 in 1 BOTTLE, UNIT-DOSE Type 0: Not a Combination Product01/11/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078501 11/01/2011 03/31/2016
DronabinolDronabinol CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8171
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dronabinol(UNII: 7J8897W37S)
(Dronabinol - UNII:7J8897W37S) 		Dronabinol5 mg
Inactive Ingredients
Ingredient Name Strength
ferric oxide red(UNII: 1K09F3G675)
ferrosoferric oxide(UNII: XM0M87F357)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
glycerin(UNII: PDC6A3C0OX)
sesame oil(UNII: QX10HYY4QV)
titanium dioxide(UNII: 15FIX9V2JP)
propylene glycol(UNII: 6DC9Q167V3)
polyvinyl acetate phthalate(UNII: 58QVG85GW3)
water(UNII: 059QF0KO0R)
isopropyl alcohol(UNII: ND2M416302)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
ammonia(UNII: 5138Q19F1X)
Product Characteristics
Color BROWN (opaque maroon or brown) Score no score
Shape CAPSULE (oval) Size 12 mm
Flavor Imprint Code INS
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-8171-9160 in 1 BOTTLE, UNIT-DOSE Type 0: Not a Combination Product01/11/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078501 11/01/2011 06/30/2016
DronabinolDronabinol CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8172
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
ferric oxide red(UNII: 1K09F3G675)
ferric oxide yellow(UNII: EX438O2MRT)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
glycerin(UNII: PDC6A3C0OX)
sesame oil(UNII: QX10HYY4QV)
titanium dioxide(UNII: 15FIX9V2JP)
propylene glycol(UNII: 6DC9Q167V3)
ferrosoferric oxide(UNII: XM0M87F357)
polyvinyl acetate phthalate(UNII: 58QVG85GW3)
water(UNII: 059QF0KO0R)
isopropyl alcohol(UNII: ND2M416302)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
ammonia(UNII: 5138Q19F1X)
Product Characteristics
Color BROWN (opaque tan) Score no score
Shape CAPSULE (oval) Size 12 mm
Flavor Imprint Code INS
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-8172-9160 in 1 BOTTLE, UNIT-DOSE Type 0: Not a Combination Product01/11/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078501 11/01/2011 05/31/2016

PRINCIPAL DISPLAY PANEL

NDC 0378-8170-91

Dronabinol
Capsules, USP

CIII

2.5 mg

Each capsule contains:
Dronabinol 2.5 mg

Mylan®

Rx only
60 Capsules

PRINCIPAL DISPLAY PANEL - 2.5 mg Capsule Bottle Carton

PRINCIPAL DISPLAY PANEL

NDC 0378-8171-91

Dronabinol
Capsules, USP

CIII

5 mg

Each capsule contains:
Dronabinol 5 mg

Mylan®

Rx only
60 Capsules

PRINCIPAL DISPLAY PANEL - 5 mg Capsule Bottle Carton

PRINCIPAL DISPLAY PANEL

NDC 0378-8172-91

Dronabinol
Capsules, USP

CIII

10 mg

Each capsule contains:
Dronabinol 10 mg

Mylan®

Rx only
60 Capsules

PRINCIPAL DISPLAY PANEL - 10 mg Capsule Bottle Carton