NDC 0054-0079

Balsalazide Disodium

Balsalazide Disodium

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

Product ID0054-0079_18c490e1-63e0-45db-91cc-95967ca9e0e0
NDC0054-0079
Product TypeHuman Prescription Drug
Proprietary NameBalsalazide Disodium
Generic NameBalsalazide Disodium
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2007-12-28
Marketing CategoryANDA / ANDA
Application NumberANDA077806
Labeler NameHikma Pharmaceuticals USA 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 0054-0079-28

280 CAPSULE in 1 BOTTLE (0054-0079-28)
Marketing Start Date2007-12-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0079-28 [00054007928]

Balsalazide Disodium CAPSULE
Marketing CategoryANDA
Application NumberANDA077806
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-12-28

Drug Details

Active Ingredients

IngredientStrength
BALSALAZIDE DISODIUM750 mg/1

OpenFDA Data

SPL SET ID:a0498308-14b2-4456-8e13-795f6fc8ea30
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 885857
  • Pharmacological Class

    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]

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

    NDCBrand NameGeneric Name
    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
    65649-101Colazalbalsalazide disodium
    65649-102GIAZObalsalazide disodium

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