mesalamine

Generic: mesalamine

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler padagis israel pharmaceuticals ltd
Dosage Form ENEMA
Routes
RECTAL
Active Ingredients

mesalamine 4 g/60mL

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-098
Product ID 45802-098_f416ded9-2018-4422-8cff-c6fc563a3772
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076751
Listing Expiration 2026-12-31
Marketing Start 2007-10-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802098
Hyphenated Format 45802-098

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 ANDA076751 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 4 g/60mL
source: ndc
Packaging
  • 28 BOTTLE in 1 CARTON (45802-098-28) / 60 mL in 1 BOTTLE
  • 7 BOTTLE in 1 CARTON (45802-098-51) / 60 mL in 1 BOTTLE
source: ndc

Packages (2)

45802-098-28 28 BOTTLE in 1 CARTON (45802-098-28) / 60 mL in 1 BOTTLE 45802-098-51 7 BOTTLE in 1 CARTON (45802-098-51) / 60 mL in 1 BOTTLE

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": "f416ded9-2018-4422-8cff-c6fc563a3772", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["238151"], "spl_set_id": ["a4ddf68d-1502-4242-89aa-c96436bdcbf6"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 BOTTLE in 1 CARTON (45802-098-28)  / 60 mL in 1 BOTTLE", "package_ndc": "45802-098-28", "marketing_start_date": "20080212"}, {"sample": false, "description": "7 BOTTLE in 1 CARTON (45802-098-51)  / 60 mL in 1 BOTTLE", "package_ndc": "45802-098-51", "marketing_start_date": "20071011"}], "brand_name": "Mesalamine", "product_id": "45802-098_f416ded9-2018-4422-8cff-c6fc563a3772", "dosage_form": "ENEMA", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "45802-098", "generic_name": "Mesalamine", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "4 g/60mL"}], "application_number": "ANDA076751", "marketing_category": "ANDA", "marketing_start_date": "20071011", "listing_expiration_date": "20261231"}