dipentum

Generic: olsalazine sodium

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name dipentum
Generic Name olsalazine sodium
Labeler viatris specialty llc
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

olsalazine sodium 250 mg/1

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 0037-6860
Product ID 0037-6860_9a4c3abc-74c9-4a2c-a8e3-fc0100d873d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019715
Listing Expiration 2026-12-31
Marketing Start 2015-05-15

Pharmacologic Class

Classes
aminosalicylate [epc] aminosalicylic acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00376860
Hyphenated Format 0037-6860

Supplemental Identifiers

RxCUI
905162 905164
UNII
Y7JEW0XG7I

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 dipentum (source: ndc)
Generic Name olsalazine sodium (source: ndc)
Application Number NDA019715 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0037-6860-10)
source: ndc

Packages (1)

0037-6860-10 100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0037-6860-10)

Ingredients (1)

olsalazine sodium (250 mg/1)

Linked Drug Pages (1)

Dipentum ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9a4c3abc-74c9-4a2c-a8e3-fc0100d873d9", "openfda": {"unii": ["Y7JEW0XG7I"], "rxcui": ["905162", "905164"], "spl_set_id": ["8512d0c6-db4e-4673-b3b4-28975c18413f"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0037-6860-10)", "package_ndc": "0037-6860-10", "marketing_start_date": "20150515"}], "brand_name": "Dipentum", "product_id": "0037-6860_9a4c3abc-74c9-4a2c-a8e3-fc0100d873d9", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "0037-6860", "generic_name": "olsalazine sodium", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dipentum", "active_ingredients": [{"name": "OLSALAZINE SODIUM", "strength": "250 mg/1"}], "application_number": "NDA019715", "marketing_category": "NDA", "marketing_start_date": "20150515", "listing_expiration_date": "20261231"}