NDC 65649-101

Colazal

Balsalazide Disodium

Colazal is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Salix Pharmaceuticals, Inc. The primary component is Balsalazide Disodium.

Product ID65649-101_293e0bad-d04d-4b49-8b35-2e5cb9ad5289
NDC65649-101
Product TypeHuman Prescription Drug
Proprietary NameColazal
Generic NameBalsalazide Disodium
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2000-07-18
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA020610
Labeler NameSalix Pharmaceuticals, Inc
Substance NameBALSALAZIDE DISODIUM
Active Ingredient Strength750 mg/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 65649-101-02

280 CAPSULE in 1 BOTTLE (65649-101-02)
Marketing Start Date2000-07-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65649-101-02 [65649010102]

Colazal CAPSULE
Marketing CategoryNDA authorized generic
Application NumberNDA020610
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-07-18

NDC 65649-101-50 [65649010150]

Colazal CAPSULE
Marketing CategoryNDA authorized generic
Application NumberNDA020610
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-07-18
Marketing End Date2011-10-31

Drug Details

Active Ingredients

IngredientStrength
BALSALAZIDE DISODIUM750 mg/1

OpenFDA Data

SPL SET ID:22f41e83-b9fb-4c9e-8cc3-f457034191a8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 885857
  • 885859
    • UPC Code
  • 0365649101021

    • Pharmacological Class

    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]

    NDC Crossover Matching brand name "Colazal" or generic name "Balsalazide Disodium"

    NDCBrand NameGeneric Name
    65649-101Colazalbalsalazide disodium
    0054-0079Balsalazide DisodiumBalsalazide Disodium
    42291-157Balsalazide DisodiumBalsalazide Disodium
    50268-102Balsalazide DisodiumBalsalazide Disodium
    60429-952Balsalazide DisodiumBalsalazide Disodium
    60505-2575Balsalazide DisodiumBalsalazide Disodium
    63629-8301Balsalazide DisodiumBalsalazide Disodium
    68682-750balsalazide disodiumbalsalazide disodium
    72789-149Balsalazide DisodiumBalsalazide Disodium
    65649-102GIAZObalsalazide disodium

    Trademark Results [Colazal]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    COLAZAL
    COLAZAL
    76025821 2534845 Live/Registered
    Salix Pharmaceuticals, Inc.
    2000-04-14
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