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United States · US · US:16729-094_50ae55f7-2f85-5d74-e063-6394a90acdb1
mycophenolate mofetil
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAccord Healthcare Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc111672909401100 CAPSULE in 1 BOTTLE (16729-094-01)
- ndc111672909416500 CAPSULE in 1 BOTTLE (16729-094-16)
Annotations
UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
A090253
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": "16729-094_50ae55f7-2f85-5d74-e063-6394a90acdb1",
"productndc": "16729-094",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "090253",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"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": "ANDA090253",
"marketing_category": "ANDA",
"nonproprietary_name": "mycophenolate mofetil",
"start_marketing_date": "20090504",
"active_numerator_strength": "250"
}Access this data programmatically
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