mesalamine

Generic: mesalamine

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler ani pharmaceuticals, inc.
Dosage Form ENEMA
Routes
RECTAL
Active Ingredients

mesalamine 4 g/60mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-420
Product ID 62559-420_def117ab-832b-4d92-b005-cf2f53d52899
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA019618
Listing Expiration 2026-12-31
Marketing Start 2016-05-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62559420
Hyphenated Format 62559-420

Supplemental Identifiers

RxCUI
238151
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 NDA019618 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 4 g/60mL
source: ndc
Packaging
  • 7 BOTTLE in 1 BOX (62559-420-07) / 60 mL in 1 BOTTLE (62559-420-11)
source: ndc

Packages (1)

62559-420-07 7 BOTTLE in 1 BOX (62559-420-07) / 60 mL in 1 BOTTLE (62559-420-11)

Ingredients (1)

mesalamine (4 g/60mL)

Linked Drug Pages (1)

Mesalamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "def117ab-832b-4d92-b005-cf2f53d52899", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["238151"], "spl_set_id": ["3cf751f2-a0c9-45d7-8acb-2bc61db0e4ac"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "7 BOTTLE in 1 BOX (62559-420-07)  / 60 mL in 1 BOTTLE (62559-420-11)", "package_ndc": "62559-420-07", "marketing_start_date": "20160513"}], "brand_name": "Mesalamine", "product_id": "62559-420_def117ab-832b-4d92-b005-cf2f53d52899", "dosage_form": "ENEMA", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "62559-420", "generic_name": "Mesalamine", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "4 g/60mL"}], "application_number": "NDA019618", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20160513", "listing_expiration_date": "20261231"}