NDC Code(s) : 0093-1041-01
Packager : Teva Pharmaceuticals USA, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diclofenac SodiumDiclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-1041
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM(UNII: QTG126297Q)
(Diclofenac - UNII:144O8QL0L1) 		DICLOFENAC SODIUM100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
D&C RED NO. 27(UNII: 2LRS185U6K)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)(UNII: ZYD53NBL45)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE K90(UNII: RDH86HJV5Z)
TALC(UNII: 7SEV7J4R1U)
TRIACETIN(UNII: XHX3C3X673)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-1041-01100 in 1 BOTTLE Type 0: Not a Combination Product28/02/2000
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075492 02/28/2000 08/31/2017

PRINCIPAL DISPLAY PANEL

NDC 0093-1041-01

DICLOFENAC
SODIUM
Extended-release
Tablets
100 mg

Once-A-Day Dosage

PHARMACIST: Dispense the Medication Guide
provided separately to each patient.

Rx only

100 TABLETS

TEVA

PRINCIPAL DISPLAY PANEL - 100 mg Tablet Label