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United States · US · US:31722-878_3b604c8c-672d-7b1e-e063-6394a90a255f

Mycophenolate Mofetil

Orange BookUNIISPL

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

Identification

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

Packs · 2

  • ndc11
    3172287801
    1 BOTTLE in 1 CARTON (31722-878-01) / 100 CAPSULE in 1 BOTTLE
  • ndc11
    3172287805
    500 CAPSULE in 1 BOTTLE (31722-878-05)

Annotations

UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
A207022
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": "31722-878_3b604c8c-672d-7b1e-e063-6394a90a255f",
  "productndc": "31722-878",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "207022",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Oct 22, 2024"
      }
    ],
    "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": "ANDA207022",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mycophenolate Mofetil",
  "start_marketing_date": "20241022",
  "active_numerator_strength": "250"
}

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