mesalamine

Generic: mesalamine

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

mesalamine 400 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-5907
Product ID 0093-5907_5c416cce-8cdd-4ce2-834d-19783189b85e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207873
Listing Expiration 2026-12-31
Marketing Start 2019-05-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00935907
Hyphenated Format 0093-5907

Supplemental Identifiers

RxCUI
1368954
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 ANDA207873 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-5907-86)
source: ndc

Packages (1)

0093-5907-86 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-5907-86)

Ingredients (1)

mesalamine (400 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": "5c416cce-8cdd-4ce2-834d-19783189b85e", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["1368954"], "spl_set_id": ["6fd0a906-e1b5-4238-a79b-a195510ddc84"], "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": "180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-5907-86)", "package_ndc": "0093-5907-86", "marketing_start_date": "20190509"}], "brand_name": "Mesalamine", "product_id": "0093-5907_5c416cce-8cdd-4ce2-834d-19783189b85e", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "0093-5907", "generic_name": "Mesalamine", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "400 mg/1"}], "application_number": "ANDA207873", "marketing_category": "ANDA", "marketing_start_date": "20190509", "listing_expiration_date": "20261231"}