NDC 60429-952

Balsalazide Disodium

Balsalazide Disodium

Balsalazide Disodium is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Gsms, Incorporated. The primary component is Balsalazide Disodium.

Product ID60429-952_7cc44d63-f3ea-3d92-e053-2991aa0a85c9
NDC60429-952
Product TypeHuman Prescription Drug
Proprietary NameBalsalazide Disodium
Generic NameBalsalazide Disodium
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-01-26
Marketing CategoryANDA / ANDA
Application NumberANDA077806
Labeler NameGSMS, Incorporated
Substance NameBALSALAZIDE DISODIUM
Active Ingredient Strength750 mg/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 60429-952-28

280 CAPSULE in 1 BOTTLE (60429-952-28)
Marketing Start Date2018-02-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60429-952-28 [60429095228]

Balsalazide Disodium CAPSULE
Marketing CategoryANDA
Application NumberANDA077806
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-26

Drug Details

Active Ingredients

IngredientStrength
BALSALAZIDE DISODIUM750 mg/1

OpenFDA Data

SPL SET ID:1596c0dd-ff24-4900-9555-e9484fe79461
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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