balsalazide disodium

Generic: balsalazide disodium

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name balsalazide disodium
Generic Name balsalazide disodium
Labeler hikma pharmaceuticals usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

balsalazide disodium 750 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0079
Product ID 0054-0079_6f5a92d7-1828-44ea-8265-0ed1b3bef16c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077806
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 00540079
Hyphenated Format 0054-0079

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 ANDA077806 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 280 CAPSULE in 1 BOTTLE (0054-0079-28)
source: ndc

Packages (1)

0054-0079-28 280 CAPSULE in 1 BOTTLE (0054-0079-28)

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": "6f5a92d7-1828-44ea-8265-0ed1b3bef16c", "openfda": {"unii": ["1XL6BJI034"], "rxcui": ["885857"], "spl_set_id": ["a0498308-14b2-4456-8e13-795f6fc8ea30"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "280 CAPSULE in 1 BOTTLE (0054-0079-28)", "package_ndc": "0054-0079-28", "marketing_start_date": "20071228"}], "brand_name": "Balsalazide Disodium", "product_id": "0054-0079_6f5a92d7-1828-44ea-8265-0ed1b3bef16c", "dosage_form": "CAPSULE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "0054-0079", "generic_name": "Balsalazide Disodium", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Balsalazide Disodium", "active_ingredients": [{"name": "BALSALAZIDE DISODIUM", "strength": "750 mg/1"}], "application_number": "ANDA077806", "marketing_category": "ANDA", "marketing_start_date": "20071228", "listing_expiration_date": "20261231"}