mesalamine

Generic: mesalamine

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler american health packaging
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

mesalamine 1.2 g/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-397
Product ID 60687-397_278689c8-9371-59ed-e063-6294a90a7bda
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091640
Listing Expiration 2026-12-31
Marketing Start 2018-10-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687397
Hyphenated Format 60687-397

Supplemental Identifiers

RxCUI
686429
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 ANDA091640 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.2 g/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-397-25) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-397-95)
source: ndc

Packages (1)

60687-397-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-397-25) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-397-95)

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": "278689c8-9371-59ed-e063-6294a90a7bda", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["686429"], "spl_set_id": ["77140634-9f32-40ca-8c83-9fcc3e373c16"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-397-25)  / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-397-95)", "package_ndc": "60687-397-25", "marketing_start_date": "20181011"}], "brand_name": "Mesalamine", "product_id": "60687-397_278689c8-9371-59ed-e063-6294a90a7bda", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "60687-397", "generic_name": "Mesalamine", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": "1.2 g/1"}], "application_number": "ANDA091640", "marketing_category": "ANDA", "marketing_start_date": "20181011", "listing_expiration_date": "20261231"}