Dronabinol (Page 4 of 4)

STORAGE CONDITIONS

Dronabinol Capsules, USP should be packaged in a well-closed container and stored in a refrigerator, 2° to 8°C (36° to 46°F).

Protect from freezing.

HOW SUPPLIED

Dronabinol Capsules (dronabinol solution in sesame oil in soft gelatin capsules)


5 mg — opaque brown, oblong softgel capsules printed “PAR 868” in black ink.


NDC 54868-5929-0 Bottle of 60 capsules




Manufactured by:
Pharmaceutics International, Inc.
Hunt Valley, MD 21031

Manufactured for:
Par Pharmaceutical Companies, Inc.
Spring Valley, NY 10977

Revised: 11/2011

OS867-15-17-02

302850-0B

Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle of 60 Capsules NDC 54868-5929-0

CIII Rx Only

image of 5 mg package label
(click image for full-size original)
DRONABINOL dronabinol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5929(NDC:49884-868)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DRONABINOL (DRONABINOL) DRONABINOL 5 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
WATER
SESAME OIL
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 40
FERROSOFERRIC OXIDE
SHELLAC
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
Product Characteristics
Color BROWN (opaque) Score no score
Shape CAPSULE (Oblong softgel) Size 12mm
Flavor Imprint Code PAR;868
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5929-0 60 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078292 08/19/2008
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 01/2012 Physicians Total Care, Inc.

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