FDA.reportPublic FDA data

NDC 0245-0822-89 - TORPENZ

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0245-0822
Requested NDC
0245-0822-89
Package NDCs from labels
0245-0822-30, 0245-0822-89, 0245-0822-04
Manufacturer
Upsher-Smith Laboratories, LLC | Biocon Pharma Limited
Effective date
2026-06-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TORPENZ - Upsher-Smith Laboratories, LLC | Biocon Pharma LimitedUpsher-Smith Laboratories, LLC | Biocon Pharma Limited2026-06-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0245-0822-04TORPENZ28 in 1 CARTONTABLET2811
0245-0822-30TORPENZ30 in 1 BOTTLETABLET3011
0245-0822-89TORPENZ1 in 1 BLISTER PACKTABLET111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0245-0822TORPENZ (EVEROLIMUS) TABLET [UPSHER-SMITH LABORATORIES, LLC]9Current NDC, 3 package rows20241120_4c0075dd-a0a8-4dc4-be32-1be8383fbbdc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0245-0822-04EA - Each0245-08227f65f100-8fb7-44bc-a431-be71f815ea8d12026-04-20
0245-0822-30EA - Each0245-082214f88f62-dd89-41fe-852b-eaf80f8c2c3512024-07-12
0245-0822-89EA - Each0245-082274b85991-8d85-4226-81ed-a09e301830cb12026-04-20

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
unii: 1P9D0Z171K
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: 1P9D0Z171K
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
unii: 1P9D0Z171K
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 1P9D0Z171K
EverolimusEVEROLIMUSNatco Pharma Limitede3dbbc24-7e55-4069-a305-e2cded2db6412023-06-08Warnings, Adverse reactionsExact identifier
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
unii: 9HW64Q8G6G

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.