MESALAMINE

Generic: MESALAMINE

Labeler: Greenstone LLC
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive

Drug Facts

Product Profile

Brand Name MESALAMINE
Generic Name MESALAMINE
Labeler Greenstone LLC
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

MESALAMINE 400 mg/1

Identifiers & Regulatory

Product NDC 59762-0117
Product ID 59762-0117_f25f71bd-9e1c-4b2e-aed6-551d2ed80e7d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA204412
Marketing Start 2019-05-10
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 597620117
Hyphenated Format 59762-0117

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 MESALAMINE (source: ndc)
Generic Name MESALAMINE (source: ndc)
Application Number NDA204412 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59762-0117-1)
source: ndc

Packages (1)

59762-0117-1 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59762-0117-1)

Ingredients (1)

MESALAMINE (400 mg/1)

Linked Drug Pages (1)

MESALAMINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f25f71bd-9e1c-4b2e-aed6-551d2ed80e7d", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["1368954"], "spl_set_id": ["370bd908-55af-4dfc-8837-913bf73babbd"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Greenstone LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59762-0117-1)", "package_ndc": "59762-0117-1", "marketing_end_date": "20260228", "marketing_start_date": "20190510"}], "brand_name": "MESALAMINE", "product_id": "59762-0117_f25f71bd-9e1c-4b2e-aed6-551d2ed80e7d", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "59762-0117", "generic_name": "MESALAMINE", "labeler_name": "Greenstone LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MESALAMINE", "active_ingredients": [{"name": "MESALAMINE", "strength": "400 mg/1"}], "application_number": "NDA204412", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20260228", "marketing_start_date": "20190510"}