Pentasa

Orange BookUNIISPLATC A07EC02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerTakeda Pharmaceuticals America, Inc.

CountryUS (United States)

ATC codeA07EC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5409219112
120 CAPSULE in 1 BOTTLE (54092-191-12)

Annotations

UNII (FDA Substance ID)

4Q81I59GXC

MESALAMINE

RxCUI 52582

Orange Book

N020049

ABAB

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": {
    "e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606": {
      "match": "brand_token",
      "title": "PENTASA (MESALAMINE) CAPSULE [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "42",
      "published_date": "2025-01-17"
    }
  },
  "productid": "54092-191_42661699-8fcc-40da-a05d-91906f9973e8",
  "productndc": "54092-191",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "020049",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "May 10, 1993"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Jul 8, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MESALAMINE",
  "proprietary_name": "Pentasa",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020049",
  "marketing_category": "NDA",
  "nonproprietary_name": "mesalamine",
  "start_marketing_date": "20040708",
  "active_numerator_strength": "500"
}

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