mesalamine

Generic: mesalamine

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler bryant ranch prepack
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

mesalamine 1000 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-2397
Product ID 63629-2397_f36797f1-e0b0-43e2-8b3c-67090bbe76e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207448
Listing Expiration 2026-12-31
Marketing Start 2019-06-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636292397
Hyphenated Format 63629-2397

Supplemental Identifiers

RxCUI
248420
UNII
4Q81I59GXC
NUI
N0000175781 M0000971

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 ANDA207448 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 5 PACKAGE in 1 CARTON (63629-2397-1) / 6 SUPPOSITORY in 1 PACKAGE
source: ndc

Packages (1)

63629-2397-1 5 PACKAGE in 1 CARTON (63629-2397-1) / 6 SUPPOSITORY in 1 PACKAGE

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": "f36797f1-e0b0-43e2-8b3c-67090bbe76e8", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["248420"], "spl_set_id": ["06792d20-d7e9-4b66-a4cb-cd0cf1a2db25"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "5 PACKAGE in 1 CARTON (63629-2397-1)  / 6 SUPPOSITORY in 1 PACKAGE", "package_ndc": "63629-2397-1", "marketing_start_date": "20210504"}], "brand_name": "Mesalamine", "product_id": "63629-2397_f36797f1-e0b0-43e2-8b3c-67090bbe76e8", "dosage_form": "SUPPOSITORY", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "63629-2397", "generic_name": "Mesalamine", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "1000 mg/1"}], "application_number": "ANDA207448", "marketing_category": "ANDA", "marketing_start_date": "20190605", "listing_expiration_date": "20261231"}