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United States · US · US:68382-452_1d3ac6ac-1404-492a-890f-5ed6e250b380
Mesalamine
Orange BookUNIISPLATC A07EC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeA07EC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116838245219120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-452-19)
Annotations
UNII (FDA Substance ID)
4Q81I59GXC
MESALAMINE
RxCUI 52582
Orange Book
A208954
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": "68382-452_1d3ac6ac-1404-492a-890f-5ed6e250b380",
"productndc": "68382-452",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "208954",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "375MG",
"product_no": "001",
"approval_date": "Aug 12, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MESALAMINE",
"proprietary_name": "Mesalamine",
"active_ingred_unit": "g/1",
"application_number": "ANDA208954",
"marketing_category": "ANDA",
"nonproprietary_name": "Mesalamine",
"start_marketing_date": "20210813",
"active_numerator_strength": ".375"
}Related drugs
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