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United States · US · US:45802-098_f416ded9-2018-4422-8cff-c6fc563a3772
Mesalamine
Orange BookUNIISPLATC A07EC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeA07EC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11458020982828 BOTTLE in 1 CARTON (45802-098-28) / 60 mL in 1 BOTTLE
- ndc1145802098517 BOTTLE in 1 CARTON (45802-098-51) / 60 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
4Q81I59GXC
MESALAMINE
RxCUI 52582
Orange Book
A076751
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": "RECTAL",
"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": "45802-098_f416ded9-2018-4422-8cff-c6fc563a3772",
"productndc": "45802-098",
"dosage_form": "ENEMA",
"orange_book": {
"appl_no": "076751",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "4GM/60ML",
"product_no": "001",
"approval_date": "Sep 17, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MESALAMINE",
"proprietary_name": "Mesalamine",
"active_ingred_unit": "g/60mL",
"application_number": "ANDA076751",
"marketing_category": "ANDA",
"nonproprietary_name": "Mesalamine",
"start_marketing_date": "20071011",
"active_numerator_strength": "4"
}Related drugs
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