Back to search
🇺🇸

United States · US · US:63304-175_3f29d761-eab5-4f6b-a4f4-ffcc072648e3

Mesalamine

Orange BookUNIISPLATC A07EC02

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeA07EC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6330417513
    120 TABLET, DELAYED RELEASE in 1 BOTTLE (63304-175-13)

Annotations

UNII (FDA Substance ID)
4Q81I59GXC
MESALAMINE
RxCUI 52582
Orange Book
A211858
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": "63304-175_3f29d761-eab5-4f6b-a4f4-ffcc072648e3",
  "productndc": "63304-175",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "211858",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.2GM",
        "product_no": "001",
        "approval_date": "Jan 25, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MESALAMINE",
  "proprietary_name": "Mesalamine",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA211858",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mesalamine",
  "start_marketing_date": "20190201",
  "active_numerator_strength": "1.2"
}

Related drugs

Other records sharing ATC code A07EC02.

Access this data programmatically

Query Mesalamine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.