mesalamine

Generic: mesalamine

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler actavis pharma, inc.
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

mesalamine 1000 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0472-1915
Product ID 0472-1915_380df1f0-2282-4c49-bd7c-40b244f875d4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205654
Marketing Start 2021-04-23
Marketing End 2026-11-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04721915
Hyphenated Format 0472-1915

Supplemental Identifiers

RxCUI
248420
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 ANDA205654 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 BOX (0472-1915-30) / 1 SUPPOSITORY in 1 POUCH (0472-1915-01)
source: ndc

Packages (1)

0472-1915-30 30 POUCH in 1 BOX (0472-1915-30) / 1 SUPPOSITORY in 1 POUCH (0472-1915-01)

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": "380df1f0-2282-4c49-bd7c-40b244f875d4", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["248420"], "spl_set_id": ["73317da3-cba0-4106-9e88-79b0e2f642af"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 BOX (0472-1915-30)  / 1 SUPPOSITORY in 1 POUCH (0472-1915-01)", "package_ndc": "0472-1915-30", "marketing_end_date": "20261130", "marketing_start_date": "20210423"}], "brand_name": "Mesalamine", "product_id": "0472-1915_380df1f0-2282-4c49-bd7c-40b244f875d4", "dosage_form": "SUPPOSITORY", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "0472-1915", "generic_name": "Mesalamine", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "1000 mg/1"}], "application_number": "ANDA205654", "marketing_category": "ANDA", "marketing_end_date": "20261130", "marketing_start_date": "20210423"}