apriso

Generic: mesalamine

Labeler: salix pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

mesalamine 375 mg/1

Manufacturer
Salix Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 65649-103
Product ID 65649-103_0e88852d-72fc-3002-e063-6394a90a0369
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022301
Listing Expiration 2026-12-31
Marketing Start 2008-10-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65649103
Hyphenated Format 65649-103

Supplemental Identifiers

RxCUI
825130 825134
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 apriso (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
  • 1 BOTTLE in 1 CARTON (65649-103-01) / 4 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (65649-103-02) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

65649-103-01 1 BOTTLE in 1 CARTON (65649-103-01) / 4 CAPSULE, EXTENDED RELEASE in 1 BOTTLE 65649-103-02 1 BOTTLE in 1 CARTON (65649-103-02) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Ingredients (1)

mesalamine (375 mg/1)

Linked Drug Pages (1)

APRISO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0e88852d-72fc-3002-e063-6394a90a0369", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["825130", "825134"], "spl_set_id": ["7951139c-b271-45a4-b523-34b23800917b"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Salix Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE in 1 CARTON (65649-103-01)  / 4 CAPSULE, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "65649-103-01", "marketing_start_date": "20081031"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65649-103-02)  / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "65649-103-02", "marketing_start_date": "20081031"}], "brand_name": "APRISO", "product_id": "65649-103_0e88852d-72fc-3002-e063-6394a90a0369", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "65649-103", "generic_name": "mesalamine", "labeler_name": "Salix Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "APRISO", "active_ingredients": [{"name": "MESALAMINE", "strength": "375 mg/1"}], "application_number": "NDA022301", "marketing_category": "NDA", "marketing_start_date": "20081031", "listing_expiration_date": "20261231"}