Gemfibrozil (Page 5 of 5)

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 are white to off-white, elliptical, biconvex, film-coated tablets, debossed with ‘E’ on one side and ‘82’ on the other side.
Bottles of 60 NDC 65862-624-60
Bottles of 500 NDC 65862-624-05
Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from light and humidity.
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India
Revised: 12/2020

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 600 mg (60 Tablet Bottle)

NDC 65862-624-60
Rx only
Gemfibrozil
Tablets, USP
600 mg
AUROBINDO 60 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 600 mg (60 Tablet Bottle)
(click image for full-size original)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 600 mg (60 Tablet Bottle)
GEMFIBROZIL gemfibrozil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-624
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
SILICON DIOXIDE
HYPROMELLOSE 2910 (6 MPA.S)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL (Elliptical, Biconvex) Size 19mm
Flavor Imprint Code E;82
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-624-60 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-624-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202726 09/16/2015
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-624), MANUFACTURE (65862-624)

Revised: 07/2021 Aurobindo Pharma Limited

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