Prescription Drug Information: Gemfibrozil (Page 4 of 4)

DOSAGE AND ADMINISTRATION

The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).

OVERDOSAGE

There have been reported cases of overdosage with gemfibrozil. In one case, a 7-year-old child recovered after ingesting up to 9 grams of gemfibrozil. Symptoms reported with overdosage were abdominal cramps, abnormal liver function tests, diarrhea, increased CPK, joint and muscle pain, nausea and vomiting. Symptomatic supportive measures should be taken, should an overdose occur.

HOW SUPPLIED

Gemfibrozil Tablets USP 600 mg: White, elliptical, film-coated, scored tablets, imprinted ‘C17′ on one side, are available as follows:

NDC 75834-131-60: Bottles of 60
NDC 75834-131-18: Bottles of 180
NDC 75834-131-05: Bottles of 500

Store at controlled room temperature 20° – 25°C (68° – 77°F) [see USP]. Protect from light and humidity.

Rx only

Manufactured for : Nivagen Pharmaceuticals, Inc.
Sacramento, CA 95827
Toll free number : 1-877-977-0687

Manufactured by : Cadila Pharmaceuticals Ltd. 1389, Dholka, Dist. Ahmedabad, Gujarat State, India.

August 2016

OBA0338

Principal Display Panel

NDC: 70934-466-90

Label
(click image for full-size original)
GEMFIBROZIL gemfibrozil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70934-466(NDC:75834-131)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GEMFIBROZIL (GEMFIBROZIL) GEMFIBROZIL 600 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE
MICROCRYSTALLINE CELLULOSE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
POLYSORBATE 80
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
SHELLAC
FD&C BLUE NO. 1
BUTYL ALCOHOL
PROPYLENE GLYCOL
ISOPROPYL ALCOHOL
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code C17
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70934-466-90 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203266 11/26/2019
Labeler — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Registrant — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Establishment
Name Address ID/FEI Operations
Denton Pharma, Inc. DBA Northwind Pharmaceuticals 080355546 repack (70934-466)

Revised: 03/2020 Denton Pharma, Inc. DBA Northwind Pharmaceuticals

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