FDA.reportPublic FDA data

NDC 70301-2001 - Temozolomide

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
70301-2001
Package NDCs from labels
70301-2001-1, 70301-2001-2
Manufacturer
OPKO Pharmaceuticals, LLC
Effective date
2026-03-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Temozolomide - OPKO Pharmaceuticals, LLCOPKO Pharmaceuticals, LLC2026-03-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70301-2001-1Temozolomide1 in 1 PACKETCAPSULE11
70301-2001-1Temozolomide5 in 1 CARTONCAPSULE51
70301-2001-2Temozolomide14 in 1 CARTONCAPSULE141
70301-2001-2Temozolomide1 in 1 PACKETCAPSULE11

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 42 of 318 · 6,355 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
C07 STRONG LIGAMENTS AND JOINTSARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALEApex Energetics Inc.bccf8c83-a6cd-e58c-e053-2a95a90a43d72026-05-13WarningsExact identifier
unii: ETJ7Z6XBU4
Smart Care PEACH BELLINI 2 HAND SANITIZERS 1.35 FL OZETHYL ALCOHOLAshtel Studios Inc.80e475a5-97d7-4ad9-9be1-0ccdb42e6fce2026-05-12WarningsExact identifier
unii: 3K9958V90M
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
Smart Care Luxury Hand Sanitizer Whispering WoodsALCOHOLShenzhen Lantern Scicence Co.,Ltd.51ab5d03-1199-75c8-e063-6294a90ab6712026-05-12WarningsExact identifier
unii: 3K9958V90M
Smart Care VANILLA BLOSSOM HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.408ba9aa-6e03-48fe-a08e-799dbaa3408c2026-05-12WarningsExact identifier
unii: 3K9958V90M
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - DarkTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.aedde765-931f-430e-9fc3-d87bde2b78cd2026-05-12WarningsExact identifier
unii: 15FIX9V2JP
Smart Care ROSEWATER HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.0a5a21d9-6832-47a2-a4bb-83781aaa61aa2026-05-12WarningsExact identifier
unii: 3K9958V90M
Smart Care LILY WATER HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.898829cb-23e0-431b-be67-246c245b3dd52026-05-12WarningsExact identifier
unii: 3K9958V90M
Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - MediumTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.417305d7-d32e-4bc9-8f77-0a42b6bdecf52026-05-12WarningsExact identifier
unii: 15FIX9V2JP
Lightning X Hand CleanserETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.51861f1e-8961-e876-e063-6394a90a2fd02026-05-11WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERETHYL ALCOHOLLESSDOTW CO.,LTD.518657d5-9ee6-f8ca-e063-6294a90af5952026-05-11WarningsExact identifier
unii: 3K9958V90M
Lightning X Sting and Bite Relief PadsBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.518698c0-a1ae-760f-e063-6394a90a51602026-05-11WarningsExact identifier
unii: ND2M416302
Beverly Gel Hand SanitizerETHYL ALCOHOLCleanslate Group LLC0e999251-cb51-ceec-e063-6294a90a35ad2026-05-11WarningsExact identifier
unii: 3K9958V90M
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
unii: 1K09F3G675
SANAR DECOLORIZED IODINEETHYL ALCOHOLEVI LABS518d399a-009e-c54f-e063-6294a90ab8382026-05-11WarningsExact identifier
unii: 3K9958V90M
Amora Hand Sanitizer WatermelonALCOHOLI World LLC45f9b0a2-972f-4d44-aad1-8999313d41912026-05-11WarningsExact identifier
unii: 3K9958V90M
The Perfect Derma Mineral Perfection Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEBella Medical Products LLC518f69fc-fd39-8195-e063-6294a90a3fdd2026-05-11WarningsExact identifier
unii: 15FIX9V2JP
Amora Hand Sanitizer CherryALCOHOLI World LLCd9445e2a-e7f0-41ab-9b89-17cdf9fd7d5f2026-05-11WarningsExact identifier
unii: 3K9958V90M
Amora Hand Sanitizer CoconutALCOHOLI World LLCdded6a0c-3bed-453e-a2ea-d3406f2c89762026-05-11WarningsExact identifier
unii: 3K9958V90M
Radical Rescue Morning UVA/UVB Defense Primer Broad Spectrum SPF 30 Universal Tint Mineral SunscreenRADICAL RESCUE SPF 30 MINERAL SUNSCREENProTransit, Inc.38e0139c-bb87-55ba-e063-6294a90a82ee2026-05-11WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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