Back to search
🇺🇸

United States · US · US:68382-435_c2b40002-6c58-4c89-b178-c915a59cb2dd

mesalamine

Orange BookUNIISPLATC A07EC02

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

Identification

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

Packs · 2

  • ndc11
    6838243528
    180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-435-28)
  • ndc11
    6838243577
    10 BLISTER PACK in 1 CARTON (68382-435-77) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68382-435-30)

Annotations

UNII (FDA Substance ID)
4Q81I59GXC
MESALAMINE
RxCUI 52582
Orange Book
A203286
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": "68382-435_c2b40002-6c58-4c89-b178-c915a59cb2dd",
  "productndc": "68382-435",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "203286",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "001",
        "approval_date": "Jul 21, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MESALAMINE",
  "proprietary_name": "mesalamine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203286",
  "marketing_category": "ANDA",
  "nonproprietary_name": "mesalamine",
  "start_marketing_date": "20180802",
  "active_numerator_strength": "800"
}

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.