Colazal (Page 6 of 6)

PRINCIPAL DISPLAY PANEL-COLAZAL 280 Capsules, Bottle Label

NDC 65649-101-02

Rx only

COLAZAL ®

(balsalazide disodium)

Capsules

750 mg

280 Capsules

Salix

PHARMACEUTICALS

label
(click image for full-size original)
COLAZAL balsalazide disodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65649-101
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BALSALAZIDE DISODIUM (BALSALAZIDE) BALSALAZIDE DISODIUM 750 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color white (Beige) Score no score
Shape CAPSULE (Capsule) Size 23mm
Flavor Imprint Code CZ
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65649-101-02 280 CAPSULE in 1 BOTTLE None
2 NDC:65649-101-50 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020610 07/18/2000
Labeler — Salix Pharmaceuticals, Inc (793108036)
Establishment
Name Address ID/FEI Operations
LGM Pharma Solutions, LLC 117549200 manufacture (65649-101)

Revised: 11/2023 Salix Pharmaceuticals, Inc

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