🇺🇸
United States · US · US:16571-246_92e26463-9c71-456e-b800-351162846b68
Mesalamine
Orange BookUNIISPLATC A07EC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeA07EC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1116571246035 BLISTER PACK in 1 CARTON (16571-246-03) / 6 SUPPOSITORY in 1 BLISTER PACK (16571-246-16)
- ndc11165712467212 BLISTER PACK in 1 CARTON (16571-246-72) / 6 SUPPOSITORY in 1 BLISTER PACK (16571-246-16)
Annotations
UNII (FDA Substance ID)
4Q81I59GXC
MESALAMINE
RxCUI 52582
Orange Book
A219028
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": "16571-246_92e26463-9c71-456e-b800-351162846b68",
"productndc": "16571-246",
"dosage_form": "SUPPOSITORY",
"orange_book": {
"appl_no": "219028",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1GM",
"product_no": "001",
"approval_date": "Apr 14, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MESALAMINE",
"proprietary_name": "Mesalamine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA219028",
"marketing_category": "ANDA",
"nonproprietary_name": "Mesalamine",
"start_marketing_date": "20250414",
"active_numerator_strength": "1000"
}Related drugs
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