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United States · US · US:21922-045_6ffc01fa-3cf5-4e6c-9760-7ff9873c82df
Mesalamine
Orange BookUNIISPLATC A07EC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEncube Ethicals, Inc.
CountryUS (United States)
ATC codeA07EC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1121922045477 BOTTLE, DISPENSING in 1 CARTON (21922-045-47) / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01)
- ndc11219220454928 BOTTLE, DISPENSING in 1 CARTON (21922-045-49) / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01)
Annotations
UNII (FDA Substance ID)
4Q81I59GXC
MESALAMINE
RxCUI 52582
Orange Book
A216941
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": "21922-045_6ffc01fa-3cf5-4e6c-9760-7ff9873c82df",
"productndc": "21922-045",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "216941",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "4GM/60ML",
"product_no": "001",
"approval_date": "May 30, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MESALAMINE",
"proprietary_name": "Mesalamine",
"active_ingred_unit": "g/60mL",
"application_number": "ANDA216941",
"marketing_category": "ANDA",
"nonproprietary_name": "Mesalamine",
"start_marketing_date": "20230601",
"active_numerator_strength": "4"
}Related drugs
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