🇺🇸
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
- ndc115409247601120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)
- ndc11540924760212 BOTTLE in 1 CARTON (54092-476-02) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)
- ndc1154092476083 CARTON in 1 CARTON (54092-476-08) / 8 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
- ndc115409247612120 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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