balsalazide disodium

Generic: balsalazide disodium

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name balsalazide disodium
Generic Name balsalazide disodium
Labeler avpak
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

balsalazide disodium 750 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-102
Product ID 50268-102_472f9b42-99d2-a541-e063-6294a90a8926
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077883
Listing Expiration 2026-12-31
Marketing Start 2014-11-06

Pharmacologic Class

Classes
aminosalicylate [epc] aminosalicylic acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268102
Hyphenated Format 50268-102

Supplemental Identifiers

RxCUI
885857
UNII
1XL6BJI034

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
  • 30 BLISTER PACK in 1 BOX (50268-102-13) / 1 CAPSULE in 1 BLISTER PACK (50268-102-11)
source: ndc

Packages (1)

50268-102-13 30 BLISTER PACK in 1 BOX (50268-102-13) / 1 CAPSULE in 1 BLISTER PACK (50268-102-11)

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": "472f9b42-99d2-a541-e063-6294a90a8926", "openfda": {"unii": ["1XL6BJI034"], "rxcui": ["885857"], "spl_set_id": ["509b83b6-cde6-393b-8560-557793b6a529"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX (50268-102-13)  / 1 CAPSULE in 1 BLISTER PACK (50268-102-11)", "package_ndc": "50268-102-13", "marketing_start_date": "20141106"}], "brand_name": "Balsalazide Disodium", "product_id": "50268-102_472f9b42-99d2-a541-e063-6294a90a8926", "dosage_form": "CAPSULE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "50268-102", "generic_name": "Balsalazide Disodium", "labeler_name": "AvPAK", "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": "20141106", "listing_expiration_date": "20261231"}