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United States · US · US:0004-0260_ad799779-cc87-4d12-9836-74375149b84b
CellCept
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenentech, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1100040260011 BOTTLE, PLASTIC in 1 CARTON (0004-0260-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- ndc1100040260431 BOTTLE, PLASTIC in 1 CARTON (0004-0260-43) / 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
N050723
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": {
"37241e87-4af4-4dc3-a1aa-ea6f20d8dc40": {
"match": "brand_token",
"title": "CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]",
"spl_version": "50",
"published_date": "2025-12-02"
}
},
"productid": "0004-0260_ad799779-cc87-4d12-9836-74375149b84b",
"productndc": "0004-0260",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "050723",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Jun 19, 1997"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MYCOPHENOLATE MOFETIL",
"proprietary_name": "CellCept",
"active_ingred_unit": "mg/1",
"application_number": "NDA050723",
"marketing_category": "NDA",
"nonproprietary_name": "Mycophenolate Mofetil",
"start_marketing_date": "19970619",
"active_numerator_strength": "500"
}Access this data programmatically
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