balsalazide disodium

Generic: balsalazide disodium

Labeler: carnegie pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name balsalazide disodium
Generic Name balsalazide disodium
Labeler carnegie pharmaceuticals, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

balsalazide disodium 750 mg/1

Manufacturer
Carnegie Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 80005-126
Product ID 80005-126_8bfef633-a30b-4aac-b768-cce1c8e151c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219422
Listing Expiration 2026-12-31
Marketing Start 2025-06-30

Pharmacologic Class

Classes
aminosalicylate [epc] aminosalicylic acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80005126
Hyphenated Format 80005-126

Supplemental Identifiers

RxCUI
885857
UPC
0380005126258
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 ANDA219422 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 280 CAPSULE in 1 BOTTLE (80005-126-25)
source: ndc

Packages (1)

80005-126-25 280 CAPSULE in 1 BOTTLE (80005-126-25)

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": "8bfef633-a30b-4aac-b768-cce1c8e151c4", "openfda": {"upc": ["0380005126258"], "unii": ["1XL6BJI034"], "rxcui": ["885857"], "spl_set_id": ["620f86cb-b6a2-4af8-a642-925dd8a1c5fe"], "manufacturer_name": ["Carnegie Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "280 CAPSULE in 1 BOTTLE (80005-126-25)", "package_ndc": "80005-126-25", "marketing_start_date": "20250630"}], "brand_name": "balsalazide disodium", "product_id": "80005-126_8bfef633-a30b-4aac-b768-cce1c8e151c4", "dosage_form": "CAPSULE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "80005-126", "generic_name": "balsalazide disodium", "labeler_name": "Carnegie Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "balsalazide disodium", "active_ingredients": [{"name": "BALSALAZIDE DISODIUM", "strength": "750 mg/1"}], "application_number": "ANDA219422", "marketing_category": "ANDA", "marketing_start_date": "20250630", "listing_expiration_date": "20261231"}