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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
- ndc1124338018011 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"
}Access this data programmatically
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