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United States · US · US:0093-5907_5c416cce-8cdd-4ce2-834d-19783189b85e

Mesalamine

Orange BookUNIISPLATC A07EC02

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeA07EC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0093590786
    180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-5907-86)

Annotations

UNII (FDA Substance ID)
4Q81I59GXC
MESALAMINE
RxCUI 52582
Orange Book
A207873
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": "0093-5907_5c416cce-8cdd-4ce2-834d-19783189b85e",
  "productndc": "0093-5907",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "207873",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "May 9, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MESALAMINE",
  "proprietary_name": "Mesalamine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207873",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mesalamine",
  "start_marketing_date": "20190509",
  "active_numerator_strength": "400"
}

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