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United States · US · US:70954-301_9411a710-a60c-4f4b-a28c-1f72d80eaf35
Mesalamine
Orange BookUNIISPLATC A07EC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA07EC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170954301207 BOTTLE in 1 CARTON (70954-301-20) / 60 mL in 1 BOTTLE (70954-301-10)
Annotations
UNII (FDA Substance ID)
4Q81I59GXC
MESALAMINE
RxCUI 52582
Orange Book
A215269
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": "70954-301_9411a710-a60c-4f4b-a28c-1f72d80eaf35",
"productndc": "70954-301",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "215269",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "4GM/60ML",
"product_no": "001",
"approval_date": "Apr 16, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MESALAMINE",
"proprietary_name": "Mesalamine",
"active_ingred_unit": "g/60mL",
"application_number": "ANDA215269",
"marketing_category": "ANDA",
"nonproprietary_name": "Mesalamine",
"start_marketing_date": "20260514",
"active_numerator_strength": "4"
}Related drugs
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