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United States · US · US:42291-489_485f7bde-a4c9-b05b-e063-6394a90a34cf
Mesalamine
Orange BookUNIISPLATC A07EC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvKARE
CountryUS (United States)
ATC codeA07EC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114229148918180 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-489-18)
Annotations
UNII (FDA Substance ID)
4Q81I59GXC
MESALAMINE
RxCUI 52582
Orange Book
A213191
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": {
"485ed763-976e-4410-a401-7ff762a931b3": {
"match": "brand_token",
"title": "MESALAMINE SUSPENSION [ANI PHARMACEUTICALS, INC.]",
"spl_version": "3",
"published_date": "2026-05-21"
}
},
"productid": "42291-489_485f7bde-a4c9-b05b-e063-6394a90a34cf",
"productndc": "42291-489",
"dosage_form": "TABLET, DELAYED RELEASE",
"orange_book": {
"appl_no": "213191",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "001",
"approval_date": "Aug 22, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MESALAMINE",
"proprietary_name": "Mesalamine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213191",
"marketing_category": "ANDA",
"nonproprietary_name": "Mesalamine",
"start_marketing_date": "20240925",
"active_numerator_strength": "800"
}Related drugs
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