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United States · US · US:70771-1110_b22ba9c9-d644-4ea2-a21d-0f8dee960c43
mesalamine
Orange BookUNIISPLATC A07EC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeA07EC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11707711110410 BLISTER PACK in 1 CARTON (70771-1110-4) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70771-1110-2)
- ndc117077111108180 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1110-8)
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": "70771-1110_b22ba9c9-d644-4ea2-a21d-0f8dee960c43",
"productndc": "70771-1110",
"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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