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United States · US · US:59651-397_904a1ef1-2677-46f0-bfdb-645d1638d5dc

Mesalamine

Orange BookUNIISPLATC A07EC02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeA07EC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5965139708
    120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-397-08)

Annotations

UNII (FDA Substance ID)
4Q81I59GXC
MESALAMINE
RxCUI 52582
Orange Book
A214477
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": "59651-397_904a1ef1-2677-46f0-bfdb-645d1638d5dc",
  "productndc": "59651-397",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "214477",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "375MG",
        "product_no": "001",
        "approval_date": "Mar 31, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MESALAMINE",
  "proprietary_name": "Mesalamine",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA214477",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mesalamine",
  "start_marketing_date": "20230331",
  "active_numerator_strength": ".375"
}

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