Gemfibrozil (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72578-066-14 in bottles of 60 Tablets

Gemfibrozil Tablets USP, 600 mg

Rx only

60 Tablets

label
(click image for full-size original)
GEMFIBROZIL gemfibrozil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72578-066
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
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
METHYLCELLULOSE (15 CPS)
POLYETHYLENE GLYCOL 6000
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code 5;53
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72578-066-06 30 TABLET in 1 BOTTLE None
2 NDC:72578-066-14 60 TABLET in 1 BOTTLE None
3 NDC:72578-066-16 90 TABLET in 1 BOTTLE None
4 NDC:72578-066-01 100 TABLET in 1 BOTTLE None
5 NDC:72578-066-05 500 TABLET in 1 BOTTLE None
6 NDC:72578-066-10 1000 TABLET in 1 BOTTLE None
7 NDC:72578-066-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (72578-066-30)
7 NDC:72578-066-30 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (72578-066-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204189 02/21/2020
Labeler — Viona Pharmaceuticals Inc (081468959)
Registrant — Cadila Healthcare Limited (650199482)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (72578-066), MANUFACTURE (72578-066)

Revised: 12/2020 Viona Pharmaceuticals Inc

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