mesalamine rectal

Generic: mesalamine

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

Drug Facts

Product Profile

Brand Name mesalamine rectal
Generic Name mesalamine
Labeler amring pharmaceuticals inc.
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

mesalamine 1000 mg/1

Manufacturer
Amring Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 69918-560
Product ID 69918-560_795356f9-9817-4b51-8de6-4504a2a48abd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208362
Listing Expiration 2026-12-31
Marketing Start 2019-06-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69918560
Hyphenated Format 69918-560

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 rectal (source: ndc)
Generic Name mesalamine (source: ndc)
Application Number ANDA208362 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 30 SUPPOSITORY in 1 BOX (69918-560-30)
source: ndc

Packages (1)

69918-560-30 30 SUPPOSITORY in 1 BOX (69918-560-30)

Ingredients (1)

mesalamine (1000 mg/1)

Linked Drug Pages (1)

Mesalamine Rectal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "795356f9-9817-4b51-8de6-4504a2a48abd", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["248420"], "spl_set_id": ["87de237c-febb-42ca-b2a4-b444396f8640"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Amring Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 SUPPOSITORY in 1 BOX (69918-560-30)", "package_ndc": "69918-560-30", "marketing_start_date": "20190624"}], "brand_name": "Mesalamine Rectal", "product_id": "69918-560_795356f9-9817-4b51-8de6-4504a2a48abd", "dosage_form": "SUPPOSITORY", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "69918-560", "generic_name": "Mesalamine", "labeler_name": "Amring Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine Rectal", "active_ingredients": [{"name": "MESALAMINE", "strength": "1000 mg/1"}], "application_number": "ANDA208362", "marketing_category": "ANDA", "marketing_start_date": "20190624", "listing_expiration_date": "20261231"}