MYCOPHENOLATE MOFETIL

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7051840360
100 POUCH in 1 BOX (70518-4036-0) / 1 CAPSULE in 1 POUCH (70518-4036-1)

Annotations

UNII (FDA Substance ID)

9242ECW6R0

MYCOPHENOLATE MOFETIL

RxCUI 68149

Orange Book

A210181

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": "70518-4036_3f9fc1fe-87b8-a8cf-e063-6394a90a2c38",
  "productndc": "70518-4036",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "210181",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jan 8, 2019"
      }
    ],
    "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": "ANDA210181",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MYCOPHENOLATE MOFETIL",
  "start_marketing_date": "20240311",
  "active_numerator_strength": "250"
}

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