mesalamine

Generic: mesalamine

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mesalamine
Generic Name mesalamine
Labeler ascend laboratories, llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

mesalamine .375 g/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-717
Product ID 67877-717_2eece16c-6316-4dc0-bf4f-25a3f1c08ae5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214242
Listing Expiration 2026-12-31
Marketing Start 2021-07-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877717
Hyphenated Format 67877-717

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 ANDA214242 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .375 g/1
source: ndc
Packaging
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (67877-717-05)
  • 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (67877-717-12)
source: ndc

Packages (2)

67877-717-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (67877-717-05) 67877-717-12 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (67877-717-12)

Ingredients (1)

mesalamine (.375 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": "2eece16c-6316-4dc0-bf4f-25a3f1c08ae5", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["825130"], "spl_set_id": ["43f69db3-81ac-4da4-a61f-fbba6299d9c2"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (67877-717-05)", "package_ndc": "67877-717-05", "marketing_start_date": "20210716"}, {"sample": false, "description": "120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (67877-717-12)", "package_ndc": "67877-717-12", "marketing_start_date": "20210716"}], "brand_name": "Mesalamine", "product_id": "67877-717_2eece16c-6316-4dc0-bf4f-25a3f1c08ae5", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "67877-717", "generic_name": "Mesalamine", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": ".375 g/1"}], "application_number": "ANDA214242", "marketing_category": "ANDA", "marketing_start_date": "20210716", "listing_expiration_date": "20261231"}