FDA.reportPublic FDA data

NDC 0245-0824-89 - 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
0245-0824
Requested NDC
0245-0824-89
Package NDCs from labels
0245-0824-30, 0245-0824-89, 0245-0824-04
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
0245-0824-04TORPENZ28 in 1 CARTONTABLET2811
0245-0824-30TORPENZ30 in 1 BOTTLETABLET3011
0245-0824-89TORPENZ1 in 1 BLISTER PACKTABLET111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0245-0824TORPENZ (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
0245-0824-04EA - Each0245-08243ce7059a-c8af-4f20-9dc5-ecd7c109607c12026-04-20
0245-0824-30EA - Each0245-08244384481c-988a-4054-bd5f-f480feff65fc12024-07-12
0245-0824-89EA - Each0245-0824cf004cbe-e5e6-4420-a0da-2c1652fa6b6c12026-04-20

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 1 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EverolimusEVEROLIMUSHikma Pharmaceuticals USA Inc.5aaf2fb7-93f6-40d6-941a-9583a3794ce72026-08-14Warnings, Adverse reactionsExact identifier
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
unii: 9HW64Q8G6G
EverolimusEVEROLIMUSi3 Pharmaceuticals, LLCbe5da0fd-8fd4-4f84-a307-f270048d503c2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
EverolimusEVEROLIMUS TABLETSBreckenridge Pharmaceutical, Inc.c7bb6ba1-9a7f-43f5-b058-ef26d4b592212026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
EverolimusEVEROLIMUSBiocon Pharma Inc.5b809dfe-c076-07c5-207e-178c3f0d32d32026-06-30Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
EverolimusEVEROLIMUSTeva Pharmaceuticals USA, Inc.e3bca36b-29ed-4a2b-a1be-a57b6af805f62026-06-29Warnings, Adverse reactionsExact identifier
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
unii: 9HW64Q8G6G
EVEROLIMUSEVEROLIMUSAmneal Pharmaceuticals NY LLC6f1ae129-c21e-4c25-84c1-a6757d9a7eb22026-06-16Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
TORPENZEVEROLIMUSUpsher-Smith Laboratories, LLC4c0075dd-a0a8-4dc4-be32-1be8383fbbdc2026-06-10Warnings, Adverse reactionsExact identifier
application number: ANDA214182
ndc (package): 0245-0822-04
ndc (package): 0245-0823-89
ndc (package): 0245-0825-04
ndc (package): 0245-0823-04
ndc (package): 0245-0825-30
ndc (package): 0245-0822-89
ndc (package): 0245-0824-30
ndc (package): 0245-0822-30
ndc (package): 0245-0825-89
ndc (package): 0245-0823-30
ndc (package): 0245-0824-89
ndc (package): 0245-0824-04
ndc (product): 0245-0825
ndc (product): 0245-0822
ndc (product): 0245-0823
ndc (product): 0245-0824
ndc11 (package): 00245082489
rxcui: 2685206
rxcui: 998189
rxcui: 845515
rxcui: 2685204
rxcui: 845507
rxcui: 2685202
rxcui: 2685208
rxcui: 1119400
spl id: 53e82eaf-5985-55b3-e063-6394a90a673a
spl set id: 4c0075dd-a0a8-4dc4-be32-1be8383fbbdc
unii: 9HW64Q8G6G
AfinitorEVEROLIMUSNovartis Pharmaceuticals Corporation2150f73a-179b-4afc-b8ce-67c85cc72f042026-06-01Warnings, Adverse reactionsExact identifier
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
unii: 9HW64Q8G6G
YulithiraEVEROLIMUSCivicaScript, LLC5e325efa-8ae6-4dac-b59b-d7c74c73186c2026-03-31Warnings, Adverse reactionsExact identifier
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
unii: 9HW64Q8G6G
everolimusEVEROLIMUSNovugen Pharma (USA) LLC.67e62e26-448d-46ec-b5a1-00dc1b5e26c62026-03-10Warnings, Adverse reactionsExact identifier
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
unii: 9HW64Q8G6G
everolimusEVEROLIMUSAurobindo Pharma Limited43ef3c29-0e25-4fdd-aea1-06a20af9bbab2026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
ZortressEVEROLIMUSNovartis Pharmaceuticals Corporatione082a024-7850-400b-a5c2-2a140612562a2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
EverolimusEVEROLIMUSAscend Laboratories, LLC2693c497-a70b-4d00-b6db-602c872e5bed2025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
EverolimusEVEROLIMUSNatco Pharma Limitedd44998bb-5deb-4ee7-a0a5-979fe3f495572025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
EverolimusEVEROLIMUSBreckenridge Pharmaceutical, Inc.01f7b5fb-be0d-4adf-acd2-6899018de9662025-09-05Warnings, Adverse reactionsExact identifier
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
unii: 9HW64Q8G6G
EverolimusEVEROLIMUSBiocon Pharma Inc.435da284-ef0e-ca90-e0db-bab9382922e02025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
EVEROLIMUSEVEROLIMUSBiocon Pharma Inc.5fb55800-f322-6bb6-9dde-622925ef28bd2025-03-21Warnings, Adverse reactionsExact identifier
application number: ANDA214182
rxcui: 998189
rxcui: 845515
rxcui: 845507
rxcui: 1119400
unii: 9HW64Q8G6G
EverolimusEVEROLIMUSPar Health USA, LLC59cb86d5-8706-4619-b074-af253d3e0b682025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
EverolimusEVEROLIMUSHikma Pharmaceuticals USA Inc.cf2dd54b-7a1d-4401-9a01-75e68235e4332024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9HW64Q8G6G
Multi-PhenolicMANNOSE, 5-HYDROXYTRYPTOPHAN, ACETALDEHYDE, ACETYLCHOLINE CHLORIDE, ASCORBICUM ACIDUM, ASPARTAME, BUTYLATED HYDROXYTOLUENE, CAFFEIC ACID, CANDIDA ALBICANS, CINNAMIC ACID, CONIFERYL ALCOHOL, COUMARINUM, DOPAMINE HYDROCHLORIDE, ESTRADIOL, GABA (GAMMA-AMINOBUTYRIC ACID), GALLICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, HYDROCORTISONE, INDOLUM, L-DOPA, L-PHENYLALANINE, MELATONIN, MENADIONE, NOREPINEPHRINE (BITARTRATE), PETROSELINUM CRISPUM, PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, PYRROLE, QUERCETIN,Energique, Inc.492b412a-01cc-48f2-bcdc-6fffcc6519632024-08-23WarningsExact identifier
unii: 1P9D0Z171K

Reported adverse events (FAERS/openFDA)#

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