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 SUPPOSITORY
Routes
RECTAL
Active Ingredients

mesalamine 1000 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-005
Product ID 31722-005_1248c2d3-b241-5551-e063-6294a90a2f4e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213377
Listing Expiration 2026-12-31
Marketing Start 2020-03-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722005
Hyphenated Format 31722-005

Supplemental Identifiers

RxCUI
248420
UPC
0331722005302 0331722005319
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 ANDA213377 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 5 PACKAGE in 1 CARTON (31722-005-30) / 6 SUPPOSITORY in 1 PACKAGE (31722-005-32)
  • 7 PACKAGE in 1 CARTON (31722-005-31) / 6 SUPPOSITORY in 1 PACKAGE (31722-005-32)
source: ndc

Packages (2)

31722-005-30 5 PACKAGE in 1 CARTON (31722-005-30) / 6 SUPPOSITORY in 1 PACKAGE (31722-005-32) 31722-005-31 7 PACKAGE in 1 CARTON (31722-005-31) / 6 SUPPOSITORY in 1 PACKAGE (31722-005-32)

Ingredients (1)

mesalamine (1000 mg/1)

Linked Drug Pages (1)

Mesalamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "1248c2d3-b241-5551-e063-6294a90a2f4e", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0331722005302", "0331722005319"], "unii": ["4Q81I59GXC"], "rxcui": ["248420"], "spl_set_id": ["efa9d039-ae1f-4cd6-98f2-e87a901dfaeb"], "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": "5 PACKAGE in 1 CARTON (31722-005-30)  / 6 SUPPOSITORY in 1 PACKAGE (31722-005-32)", "package_ndc": "31722-005-30", "marketing_start_date": "20200319"}, {"sample": false, "description": "7 PACKAGE in 1 CARTON (31722-005-31)  / 6 SUPPOSITORY in 1 PACKAGE (31722-005-32)", "package_ndc": "31722-005-31", "marketing_start_date": "20200319"}], "brand_name": "Mesalamine", "product_id": "31722-005_1248c2d3-b241-5551-e063-6294a90a2f4e", "dosage_form": "SUPPOSITORY", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "31722-005", "generic_name": "Mesalamine", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "1000 mg/1"}], "application_number": "ANDA213377", "marketing_category": "ANDA", "marketing_start_date": "20200319", "listing_expiration_date": "20261231"}