mesalamine

Generic: mesalamine

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

mesalamine 1.2 g/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 63304-175
Product ID 63304-175_3f29d761-eab5-4f6b-a4f4-ffcc072648e3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211858
Listing Expiration 2026-12-31
Marketing Start 2019-02-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63304175
Hyphenated Format 63304-175

Supplemental Identifiers

RxCUI
686429
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 ANDA211858 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.2 g/1
source: ndc
Packaging
  • 120 TABLET, DELAYED RELEASE in 1 BOTTLE (63304-175-13)
source: ndc

Packages (1)

63304-175-13 120 TABLET, DELAYED RELEASE in 1 BOTTLE (63304-175-13)

Ingredients (1)

mesalamine (1.2 g/1)

Linked Drug Pages (1)

Mesalamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3f29d761-eab5-4f6b-a4f4-ffcc072648e3", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["686429"], "spl_set_id": ["fd8b02de-7dfa-444d-a1f8-1436b578e0cb"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (63304-175-13)", "package_ndc": "63304-175-13", "marketing_start_date": "20190201"}], "brand_name": "Mesalamine", "product_id": "63304-175_3f29d761-eab5-4f6b-a4f4-ffcc072648e3", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "63304-175", "generic_name": "Mesalamine", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "1.2 g/1"}], "application_number": "ANDA211858", "marketing_category": "ANDA", "marketing_start_date": "20190201", "listing_expiration_date": "20261231"}