mesalamine

Generic: mesalamine

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

mesalamine .375 g/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-6056
Product ID 0832-6056_44e0cd4f-abe7-5e61-e063-6294a90a988b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217533
Listing Expiration 2026-12-31
Marketing Start 2023-06-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 08326056
Hyphenated Format 0832-6056

Supplemental Identifiers

RxCUI
825130
UPC
0308326056122
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 ANDA217533 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .375 g/1
source: ndc
Packaging
  • 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-6056-12)
source: ndc

Packages (1)

0832-6056-12 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-6056-12)

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": "44e0cd4f-abe7-5e61-e063-6294a90a988b", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0308326056122"], "unii": ["4Q81I59GXC"], "rxcui": ["825130"], "spl_set_id": ["1e6978d0-01db-477d-a90f-27561777480f"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-6056-12)", "package_ndc": "0832-6056-12", "marketing_start_date": "20230725"}], "brand_name": "Mesalamine", "product_id": "0832-6056_44e0cd4f-abe7-5e61-e063-6294a90a988b", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "0832-6056", "generic_name": "Mesalamine", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mesalamine", "active_ingredients": [{"name": "MESALAMINE", "strength": ".375 g/1"}], "application_number": "ANDA217533", "marketing_category": "ANDA", "marketing_start_date": "20230606", "listing_expiration_date": "20261231"}