mesalamine

Generic: mesalamine

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler camber pharmaceuticals, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

mesalamine 375 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-489
Product ID 31722-489_4597df51-7ed6-14f4-e063-6294a90afb23
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219864
Listing Expiration 2026-12-31
Marketing Start 2025-08-13

Pharmacologic Class

Established (EPC)
aminosalicylate [epc]
Chemical Structure
aminosalicylic acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722489
Hyphenated Format 31722-489

Supplemental Identifiers

RxCUI
825130
UPC
0331722489126
UNII
4Q81I59GXC
NUI
N0000175781 M0000971

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 mesalamine (source: ndc)
Generic Name mesalamine (source: ndc)
Application Number ANDA219864 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-489-12)
source: ndc

Packages (1)

31722-489-12 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-489-12)

Ingredients (1)

mesalamine (375 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": "4597df51-7ed6-14f4-e063-6294a90afb23", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0331722489126"], "unii": ["4Q81I59GXC"], "rxcui": ["825130"], "spl_set_id": ["ef471372-8d9f-4d95-9371-44522c69058f"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-489-12)", "package_ndc": "31722-489-12", "marketing_start_date": "20250813"}], "brand_name": "MESALAMINE", "product_id": "31722-489_4597df51-7ed6-14f4-e063-6294a90afb23", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "31722-489", "generic_name": "MESALAMINE", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MESALAMINE", "active_ingredients": [{"name": "MESALAMINE", "strength": "375 mg/1"}], "application_number": "ANDA219864", "marketing_category": "ANDA", "marketing_start_date": "20250813", "listing_expiration_date": "20261231"}