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United States · US · US:73190-010_339a10d4-599c-e16c-e063-6294a90aa2a2

Mycophenolate mofetil

Orange BookUNIISPL

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

Identification

ManufacturerAvKARE
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7319001001
    100 TABLET, FILM COATED in 1 BOTTLE (73190-010-01)
  • ndc11
    7319001050
    500 TABLET, FILM COATED in 1 BOTTLE (73190-010-50)

Annotations

UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
A090456
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": "73190-010_339a10d4-599c-e16c-e063-6294a90aa2a2",
  "productndc": "73190-010",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090456",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Jun 10, 2010"
      }
    ],
    "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": "ANDA090456",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mycophenolate mofetil",
  "start_marketing_date": "20250425",
  "active_numerator_strength": "500"
}

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