mycophenolate mofetil

Orange BookUNIISPL

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

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6787726601
100 CAPSULE in 1 BOTTLE (67877-266-01)
ndc11
6787726605
500 CAPSULE in 1 BOTTLE (67877-266-05)
ndc11
6787726638
10 BLISTER PACK in 1 CARTON (67877-266-38) / 10 CAPSULE in 1 BLISTER PACK
ndc11
6787726684
3 BLISTER PACK in 1 CARTON (67877-266-84) / 10 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

9242ECW6R0

MYCOPHENOLATE MOFETIL

RxCUI 68149

Orange Book

A200197

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": "67877-266_f8b5a092-55fd-4e91-aa56-98fe69f1c091",
  "productndc": "67877-266",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "200197",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jun 13, 2013"
      }
    ],
    "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": "ANDA200197",
  "marketing_category": "ANDA",
  "nonproprietary_name": "mycophenolate mofetil",
  "start_marketing_date": "20100101",
  "active_numerator_strength": "250"
}

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