Back to search
🇺🇸

United States · US · US:0832-6056_44e0cd4f-abe7-5e61-e063-6294a90a988b

Mesalamine

Orange BookUNIISPLATC A07EC02

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeA07EC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0832605612
    120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-6056-12)

Annotations

UNII (FDA Substance ID)
4Q81I59GXC
MESALAMINE
RxCUI 52582
Orange Book
A217533
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": "0832-6056_44e0cd4f-abe7-5e61-e063-6294a90a988b",
  "productndc": "0832-6056",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "217533",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "375MG",
        "product_no": "001",
        "approval_date": "Jun 6, 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": "ANDA217533",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mesalamine",
  "start_marketing_date": "20230606",
  "active_numerator_strength": ".375"
}

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.