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United States · US · US:0781-2067_8d255117-cfa8-4893-8e2e-945eee7b12c4

Mycophenolate Mofetil

Orange BookUNIISPL

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

Identification

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

Packs · 4

  • ndc11
    0781206701
    100 CAPSULE in 1 BOTTLE (0781-2067-01)
  • ndc11
    0781206705
    500 CAPSULE in 1 BOTTLE (0781-2067-05)
  • ndc11
    0781206772
    120 CAPSULE in 1 BOTTLE (0781-2067-72)
  • ndc11
    0781206789
    12 CAPSULE in 1 CARTON (0781-2067-89)

Annotations

UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
A065379
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": "0781-2067_8d255117-cfa8-4893-8e2e-945eee7b12c4",
  "productndc": "0781-2067",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "065379",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Oct 15, 2008"
      }
    ],
    "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": "ANDA065379",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mycophenolate Mofetil",
  "start_marketing_date": "20081015",
  "active_numerator_strength": "250"
}

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