NDC 16729-221 - Temsirolimus

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
16729-221
Package NDCs from labels
16729-221-30
Manufacturer
Accord Healthcare Inc. | Intas Pharmaceuticals Limited
Effective date
2024-02-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Temsirolimus - Accord Healthcare Inc. | Intas Pharmaceuticals LimitedAccord Healthcare Inc. | Intas Pharmaceuticals Limited2024-02-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-221-30Temsirolimus1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE1 mL25 mg in 1mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-221TEMSIROLIMUS KIT [ACCORD HEALTHCARE INC.]3Unmatched20240216_ae8d2354-7ddb-41b8-9d55-77c84782b18f.zip

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 133 of 153 · 3,055 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Instant Hand Sanitizer Aloe VeraETHYL ALCOHOLRejoice International, Inc.1e28454c-f5d8-4d6e-91f9-bc4501b027c12024-02-28WarningsExact identifier
unii: 3K9958V90M
Instant Hand Sanitizer - ClearETHYL ALCOHOLRejoice International, Inc.f0e637d9-d61e-466d-9e05-f906639dbaca2024-02-28WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerETHYL ALCOHOLRejoice International, Inc.07b163e4-8f67-44e7-b5ef-f237023080e02024-02-28WarningsExact identifier
unii: 3K9958V90M
Instant Hand Sanitizer - Ice ClearETHYL ALCOHOLRejoice International, Inc.605ec88a-2f4c-4716-8522-eb2748b433982024-02-28WarningsExact identifier
unii: 3K9958V90M
Instant Hand Sanitizer - OriginalETHYL ALCOHOLRejoice International, Inc.bb9cc886-275e-4996-99dc-529f928b49052024-02-28WarningsExact identifier
unii: 3K9958V90M
XtraCare Hand Sanitizer Moisurize with Vitamin E and AloeETHYL ALCOHOLRejoice International2851ad2a-e108-424c-86d6-c898567695ef2024-02-28WarningsExact identifier
unii: 3K9958V90M
XtraCare Hand Sanitizer Moisturize with Vitamin EETHYL ALCOHOLRejoice International13c99570-0859-4310-843a-5eb266698eb32024-02-28WarningsExact identifier
unii: 3K9958V90M
XtraCare Instant Hand SanitizerETHYL ALCOHOLRejoice Internationala339dfd9-7cb8-4198-bc2a-9759648cf34e2024-02-28WarningsExact identifier
unii: 3K9958V90M
XtraCare Instant Hand SanitizerETHYL ALCOHOLRejoice Internationalf15a90e2-4a1e-452a-b9ac-5eb6f7b3dc722024-02-28WarningsExact identifier
unii: 3K9958V90M
Han-I-Size UnscentedALCOHOLMomar Incorporated12d843ae-8175-264d-e063-6294a90ac8c02024-02-23WarningsExact identifier
unii: 3K9958V90M
AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZERETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd11ef87cc-6ff6-511b-e063-6294a90a662f2024-02-21WarningsExact identifier
unii: 3K9958V90M
AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZERETHYL ALCOHOLMY IMPORTS USA LLC11f19126-6abb-b14c-e063-6294a90a4e342024-02-21WarningsExact identifier
unii: 3K9958V90M
TemsirolimusTEMSIROLIMUSAccord Healthcare Inc.ae8d2354-7ddb-41b8-9d55-77c84782b18f2024-02-15Warnings, Adverse reactionsExact identifier
application number: ANDA203153
ndc (package): 16729-222-30
ndc (package): 16729-223-61
ndc (package): 16729-221-30
ndc (product): 16729-223
rxcui: 722289
spl id: 116814b6-e438-8a45-e063-6394a90a9fad
spl set id: ae8d2354-7ddb-41b8-9d55-77c84782b18f
Instant Hand SanitizerALCOHOLSafetec of America, Inc.016f9770-3dd5-4480-a687-f9bb2ea73e862024-02-12WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLSafetec of America, Inc.89251271-2cb4-4445-894c-153211b752022024-02-08WarningsExact identifier
unii: 3K9958V90M
AntisepticALCOHOL, LIDOCAINE HYDROCHLORIDESafetec of America, Inc.71aeaf86-2b4d-4945-9606-a9db0ab6b7262024-02-07WarningsExact identifier
unii: 3K9958V90M
ArmiCare Hand SanitizerALCOHOLArmis Biopharma, Incacd02e65-7dfb-4d72-af5d-8063cce982f62024-02-06WarningsExact identifier
unii: 3K9958V90M
AntisepticALCOHOLSafetec of America, Inc.aeecceb7-0753-4908-b1a2-d7e18ba350ec2024-02-05WarningsExact identifier
unii: 3K9958V90M
AntimicrobialALCOHOLSafetec of America, Inc.4a070d45-f7fd-4eab-a2ba-48445d54fe5d2024-02-05WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLTEKWELD SOLUTIONS, INC.45af86a4-a413-0309-e054-00144ff88e882024-02-05WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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