Gemfibrozil (Page 5 of 5)

DOSAGE AND ADMINISTRATION

The recommended dose for adults is 1,200 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

Supplied as White film-coated, capsule shaped, biconvex tablets de-bossed with I on the left side of bisect and G on the right side of bisect on one side and 225 on the other.

NDC 70934-255-30: Bottles of 30

NDC 70934-255-60: Bottles of 60

NDC 70934-255-90: Bottles of 90

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

Manufactured by:

InvaGen Pharmaceuticals, Inc.

(a subsidiary of Cipla Ltd.)

Hauppauge, NY 11788

Manufactured for:

Cipla USA, Inc.

10 Independence Boulevard, Suite 300

Warren, NJ 07059

Revised:03/2020

Barcode: 821-03-2020

SAP code: 21081982

Principal Display Panel

NDC: 70934-255-60

label
(click image for full-size original)
GEMFIBROZIL gemfibrozil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70934-255(NDC:69097-821)
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CALCIUM STEARATE
MICROCRYSTALLINE CELLULOSE
METHYLCELLULOSE (15 MPA.S)
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code 225;IG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70934-255-30 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:70934-255-60 60 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:70934-255-90 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077836 01/22/2019
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 (70934-255)

Revised: 08/2021 Denton Pharma, Inc. dba Northwind Pharmaceuticals

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