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United States · US · US:50090-4275_bb6d7460-3900-4940-8564-af7078969144

Mycophenolate Mofetil

Orange BookUNIISPL

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009042750
    180 TABLET, FILM COATED in 1 BOTTLE (50090-4275-0)

Annotations

UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
A091249
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9242ECW6R0",
    "rxcui": "68149",
    "inchikey": "RTGDFNSFWBGLEC-SYZQJQIISA-N",
    "display_name": "MYCOPHENOLATE MOFETIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "21ff53b0-b4ba-4473-91e4-76ef41681064": {
      "match": "brand_token",
      "title": "MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC]",
      "spl_version": "30",
      "published_date": "2026-05-28"
    }
  },
  "productid": "50090-4275_bb6d7460-3900-4940-8564-af7078969144",
  "productndc": "50090-4275",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091249",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Nov 4, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MYCOPHENOLATE MOFETIL",
  "proprietary_name": "Mycophenolate Mofetil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091249",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mycophenolate Mofetil",
  "start_marketing_date": "20111128",
  "active_numerator_strength": "500"
}

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