balsalazide disodium

Generic: balsalazide disodium

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

balsalazide disodium 750 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 70710-1626
Product ID 70710-1626_5364926a-5a07-440a-a27e-1435a9e4d4f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217592
Listing Expiration 2026-12-31
Marketing Start 2023-08-25

Pharmacologic Class

Classes
aminosalicylate [epc] aminosalicylic acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101626
Hyphenated Format 70710-1626

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 ANDA217592 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 280 CAPSULE in 1 BOTTLE (70710-1626-1)
source: ndc

Packages (1)

70710-1626-1 280 CAPSULE in 1 BOTTLE (70710-1626-1)

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": "5364926a-5a07-440a-a27e-1435a9e4d4f9", "openfda": {"unii": ["1XL6BJI034"], "rxcui": ["885857"], "spl_set_id": ["0ed73067-e2ca-4184-a93a-5a2141bb4898"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "280 CAPSULE in 1 BOTTLE (70710-1626-1)", "package_ndc": "70710-1626-1", "marketing_start_date": "20230825"}], "brand_name": "balsalazide disodium", "product_id": "70710-1626_5364926a-5a07-440a-a27e-1435a9e4d4f9", "dosage_form": "CAPSULE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "70710-1626", "generic_name": "balsalazide disodium", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "balsalazide disodium", "active_ingredients": [{"name": "BALSALAZIDE DISODIUM", "strength": "750 mg/1"}], "application_number": "ANDA217592", "marketing_category": "ANDA", "marketing_start_date": "20230825", "listing_expiration_date": "20261231"}