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United States · US · US:82804-033_ce06afcb-4e6c-4b78-8bad-9909c8fffa52

Mycophenolate mofetil

Orange BookUNIISPL

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

Identification

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

Packs · 3

  • ndc11
    8280403330
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-30)
  • ndc11
    8280403360
    60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-60)
  • ndc11
    8280403390
    90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-033-90)

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": "82804-033_ce06afcb-4e6c-4b78-8bad-9909c8fffa52",
  "productndc": "82804-033",
  "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": "20221015",
  "active_numerator_strength": "500"
}

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