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United States · US · US:68382-435_c2b40002-6c58-4c89-b178-c915a59cb2dd
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 · 2
- ndc116838243528180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-435-28)
- ndc11683824357710 BLISTER PACK in 1 CARTON (68382-435-77) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68382-435-30)
Annotations
UNII (FDA Substance ID)
4Q81I59GXC
MESALAMINE
RxCUI 52582
Orange Book
A203286
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": "68382-435_c2b40002-6c58-4c89-b178-c915a59cb2dd",
"productndc": "68382-435",
"dosage_form": "TABLET, DELAYED RELEASE",
"orange_book": {
"appl_no": "203286",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "001",
"approval_date": "Jul 21, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MESALAMINE",
"proprietary_name": "mesalamine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203286",
"marketing_category": "ANDA",
"nonproprietary_name": "mesalamine",
"start_marketing_date": "20180802",
"active_numerator_strength": "800"
}Related drugs
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