balsalazide disodium

Generic: balsalazide disodium

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name balsalazide disodium
Generic Name balsalazide disodium
Labeler apotex corp.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

balsalazide disodium 750 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-2575
Product ID 60505-2575_18469dde-9cd3-fbc8-40ba-8b17b6a9c07a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077883
Listing Expiration 2026-12-31
Marketing Start 2007-12-28

Pharmacologic Class

Classes
aminosalicylate [epc] aminosalicylic acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605052575
Hyphenated Format 60505-2575

Supplemental Identifiers

RxCUI
885857
UNII
1XL6BJI034

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name balsalazide disodium (source: ndc)
Generic Name balsalazide disodium (source: ndc)
Application Number ANDA077883 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (60505-2575-0) / 10 CAPSULE in 1 BLISTER PACK
  • 30 CAPSULE in 1 BOTTLE (60505-2575-3)
  • 350 CAPSULE in 1 BOTTLE (60505-2575-4)
  • 280 CAPSULE in 1 BOTTLE (60505-2575-7)
source: ndc

Packages (4)

60505-2575-0 10 BLISTER PACK in 1 CARTON (60505-2575-0) / 10 CAPSULE in 1 BLISTER PACK 60505-2575-3 30 CAPSULE in 1 BOTTLE (60505-2575-3) 60505-2575-4 350 CAPSULE in 1 BOTTLE (60505-2575-4) 60505-2575-7 280 CAPSULE in 1 BOTTLE (60505-2575-7)

Ingredients (1)

balsalazide disodium (750 mg/1)

Linked Drug Pages (1)

Balsalazide Disodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "18469dde-9cd3-fbc8-40ba-8b17b6a9c07a", "openfda": {"unii": ["1XL6BJI034"], "rxcui": ["885857"], "spl_set_id": ["f12ffa32-d14b-e9d9-e957-2ef08b64e8b4"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (60505-2575-0)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "60505-2575-0", "marketing_start_date": "20071228"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (60505-2575-3)", "package_ndc": "60505-2575-3", "marketing_start_date": "20071228"}, {"sample": false, "description": "350 CAPSULE in 1 BOTTLE (60505-2575-4)", "package_ndc": "60505-2575-4", "marketing_start_date": "20071228"}, {"sample": false, "description": "280 CAPSULE in 1 BOTTLE (60505-2575-7)", "package_ndc": "60505-2575-7", "marketing_start_date": "20071228"}], "brand_name": "Balsalazide Disodium", "product_id": "60505-2575_18469dde-9cd3-fbc8-40ba-8b17b6a9c07a", "dosage_form": "CAPSULE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "60505-2575", "generic_name": "Balsalazide Disodium", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Balsalazide Disodium", "active_ingredients": [{"name": "BALSALAZIDE DISODIUM", "strength": "750 mg/1"}], "application_number": "ANDA077883", "marketing_category": "ANDA", "marketing_start_date": "20071228", "listing_expiration_date": "20261231"}