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United States · US · US:24338-018_d90d3f5a-98a2-4e50-8bb1-db76875c9b8c

MYHIBBIN

Orange BookUNIISPL

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

Identification

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

Packs · 1

  • ndc11
    2433801801
    1 BOTTLE, PLASTIC in 1 CARTON (24338-018-01) / 175 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
N216482
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": {
    "d9af72d6-7b3e-4c08-94b9-1d8b499cb7f9": {
      "match": "brand_token",
      "title": "MYHIBBIN (MYCOPHENOLATE MOFETIL) SUSPENSION [AZURITY PHARMACEUTICALS, INC.]",
      "spl_version": "5",
      "published_date": "2026-04-09"
    }
  },
  "productid": "24338-018_d90d3f5a-98a2-4e50-8bb1-db76875c9b8c",
  "productndc": "24338-018",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "216482",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "200MG/ML",
        "product_no": "001",
        "approval_date": "May 1, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MYCOPHENOLATE MOFETIL",
  "proprietary_name": "MYHIBBIN",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA216482",
  "marketing_category": "NDA",
  "nonproprietary_name": "MYCOPHENOLATE MOFETIL",
  "start_marketing_date": "20240610",
  "active_numerator_strength": "200"
}

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