Diflunisal (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68382-530-01 in bottle of 100 Tablets

Diflunisal Tablets USP, 500 mg

Rx only

100 TABLETS

ZYDUS

label
(click image for full-size original)
DIFLUNISAL diflunisal tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-530
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIFLUNISAL (DIFLUNISAL) DIFLUNISAL 500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
HYPROMELLOSES
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (LIGHT BLUE TO BLUE) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code 530
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-530-06 30 TABLET in 1 BOTTLE None
2 NDC:68382-530-14 60 TABLET in 1 BOTTLE None
3 NDC:68382-530-16 90 TABLET in 1 BOTTLE None
4 NDC:68382-530-01 100 TABLET in 1 BOTTLE None
5 NDC:68382-530-05 500 TABLET in 1 BOTTLE None
6 NDC:68382-530-10 1000 TABLET in 1 BOTTLE None
7 NDC:68382-530-30 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
7 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68382-530-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203547 09/14/2017
Labeler — Zydus Pharmaceuticals (USA) Inc. (156861945)
Registrant — Zydus Pharmaceuticals (USA) Inc. (156861945)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 677605858 ANALYSIS (68382-530), MANUFACTURE (68382-530)

Revised: 04/2021 Zydus Pharmaceuticals (USA) Inc.

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