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United States · US · US:54092-476_405a190f-df13-4578-a988-5b291b284f21

Lialda

Orange BookUNIISPLATC A07EC02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC codeA07EC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    5409247601
    120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)
  • ndc11
    5409247602
    12 BOTTLE in 1 CARTON (54092-476-02) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)
  • ndc11
    5409247608
    3 CARTON in 1 CARTON (54092-476-08) / 8 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • ndc11
    5409247612
    120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-12)

Annotations

UNII (FDA Substance ID)
4Q81I59GXC
MESALAMINE
RxCUI 52582
Orange Book
N022000
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4Q81I59GXC",
    "rxcui": "52582",
    "inchikey": "KBOPZPXVLCULAV-UHFFFAOYSA-N",
    "display_name": "MESALAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3098a080-be86-4265-9818-7fc4beab77b7": {
      "match": "brand_token",
      "title": "LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "49",
      "published_date": "2026-03-26"
    }
  },
  "productid": "54092-476_405a190f-df13-4578-a988-5b291b284f21",
  "productndc": "54092-476",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "022000",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "1.2GM",
        "product_no": "001",
        "approval_date": "Jan 16, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MESALAMINE",
  "proprietary_name": "Lialda",
  "active_ingred_unit": "g/1",
  "application_number": "NDA022000",
  "marketing_category": "NDA",
  "nonproprietary_name": "mesalamine",
  "start_marketing_date": "20070116",
  "active_numerator_strength": "1.2"
}

Related drugs

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