lialda

Generic: mesalamine

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

Drug Facts

Product Profile

Brand Name lialda
Generic Name mesalamine
Labeler takeda pharmaceuticals america, inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

mesalamine 1.2 g/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 54092-476
Product ID 54092-476_889a73e4-445d-4391-87d1-49baa09e7722
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022000
Listing Expiration 2026-12-31
Marketing Start 2007-01-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54092476
Hyphenated Format 54092-476

Supplemental Identifiers

RxCUI
686429 686433
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 lialda (source: ndc)
Generic Name mesalamine (source: ndc)
Application Number NDA022000 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.2 g/1
source: ndc
Packaging
  • 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)
  • 12 BOTTLE in 1 CARTON (54092-476-02) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)
  • 3 CARTON in 1 CARTON (54092-476-08) / 8 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-12)
source: ndc

Packages (4)

54092-476-01 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01) 54092-476-02 12 BOTTLE in 1 CARTON (54092-476-02) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01) 54092-476-08 3 CARTON in 1 CARTON (54092-476-08) / 8 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK 54092-476-12 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-12)

Ingredients (1)

mesalamine (1.2 g/1)

Linked Drug Pages (1)

Lialda ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "889a73e4-445d-4391-87d1-49baa09e7722", "openfda": {"nui": ["N0000175781", "M0000971"], "unii": ["4Q81I59GXC"], "rxcui": ["686429", "686433"], "spl_set_id": ["3098a080-be86-4265-9818-7fc4beab77b7"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)", "package_ndc": "54092-476-01", "marketing_start_date": "20070116"}, {"sample": false, "description": "12 BOTTLE in 1 CARTON (54092-476-02)  / 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)", "package_ndc": "54092-476-02", "marketing_start_date": "20070116"}, {"sample": false, "description": "3 CARTON in 1 CARTON (54092-476-08)  / 8 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "54092-476-08", "marketing_start_date": "20070116"}, {"sample": false, "description": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-12)", "package_ndc": "54092-476-12", "marketing_start_date": "20070116"}], "brand_name": "Lialda", "product_id": "54092-476_889a73e4-445d-4391-87d1-49baa09e7722", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "54092-476", "generic_name": "mesalamine", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lialda", "active_ingredients": [{"name": "MESALAMINE", "strength": "1.2 g/1"}], "application_number": "NDA022000", "marketing_category": "NDA", "marketing_start_date": "20070116", "listing_expiration_date": "20261231"}