mesalamine

Generic: mesalamine

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

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler teva pharmaceuticals usa, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

mesalamine 375 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-9224
Product ID 0093-9224_0ce3f59e-e447-81a0-e063-6394a90ab0c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022301
Listing Expiration 2026-12-31
Marketing Start 2021-01-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00939224
Hyphenated Format 0093-9224

Supplemental Identifiers

RxCUI
825130
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 NDA022301 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-9224-89)
source: ndc

Packages (1)

0093-9224-89 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-9224-89)

Ingredients (1)

mesalamine (375 mg/1)

Linked Drug Pages (1)

mesalamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0ce3f59e-e447-81a0-e063-6394a90ab0c3", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["825130"], "spl_set_id": ["8d27a608-3ba1-4799-be38-c00fb08ce3ce"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-9224-89)", "package_ndc": "0093-9224-89", "marketing_start_date": "20210105"}], "brand_name": "mesalamine", "product_id": "0093-9224_0ce3f59e-e447-81a0-e063-6394a90ab0c3", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "0093-9224", "generic_name": "mesalamine", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "375 mg/1"}], "application_number": "NDA022301", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20210105", "listing_expiration_date": "20261231"}