Mycophenolate Mofetil

Orange BookUNIISPL

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
7161003353
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-53)
ndc11
7161003360
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-60)
ndc11
7161003370
120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-70)
ndc11
7161003380
180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-80)
ndc11
7161003390
240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-90)
ndc11
7161003392
270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-92)
ndc11
7161003398
540 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-98)

Annotations

UNII (FDA Substance ID)

9242ECW6R0

MYCOPHENOLATE MOFETIL

RxCUI 68149

Orange Book

A065521

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": "71610-033_11d3eb0d-489b-06c5-e063-6294a90a9d3b",
  "productndc": "71610-033",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "065521",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "May 4, 2009"
      }
    ],
    "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": "ANDA065521",
  "marketing_category": "ANDA",
  "nonproprietary_name": "mycophenolate mofetil",
  "start_marketing_date": "20150106",
  "active_numerator_strength": "500"
}

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