Diclofenac Sodium and Misoprostol (Page 11 of 11)

PRINCIPAL DISPLAY PANEL

NDC 68788-9290
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, USP

75 mg/0.2 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

Diclofenac Sodium & Misoprostol D-R Tab 75mg/0.2mg
(click image for full-size original)
DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium and misoprostol tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-9290(NDC:0591-0398)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM (DICLOFENAC) DICLOFENAC SODIUM 75 mg
MISOPROSTOL (MISOPROSTOL) MISOPROSTOL 200 ug
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
HYDROGENATED CASTOR OIL
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM HYDROXIDE
STARCH, CORN
TALC
TRIETHYL CITRATE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 0398
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-9290-6 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:68788-9290-3 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201089 03/02/2015
Labeler — Preferred Pharmaceuticals, Inc. (791119022)
Registrant — Preferred Pharmaceuticals, Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc. 791119022 REPACK (68788-9290)

Revised: 04/2022 Preferred Pharmaceuticals, Inc.

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