FDA.reportPublic FDA data

TEMOZOLOMIDE

Product NDC
59923-704
11-digit product format
599230704
Labeler code
59923
Product ID
59923-704_c1241f17-210e-2d38-e053-2a95a90a56ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Areva Pharmaceuticals
Application
ANDA204639
Marketing category
ANDA
Marketing start
2019-01-25
Marketing end
0000-00-00
Substance
TEMOZOLOMIDE
Active strength
5 mg/1
Pharmacologic classes
Alkylating Activity [MoA],Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
3afbbf09-a1e0-475e-b654-466d26d19d69Product name920170706

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59923-704-142026-01-29C16284748780-1f386c649-f525-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES USP safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES USP. TEMOZOLOMIDE capsules USP, for oral use Initial U.S. Approval: 1999
59923-704-142024-02-02C16284748780-1f386c649-f525-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES USP safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES USP. TEMOZOLOMIDE capsules USP, for oral use Initial U.S. Approval: 1999
59923-704-142023-01-30C16284748780-1f386c649-f525-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES USP safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES USP. TEMOZOLOMIDE capsules USP, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59923-704-14TEMOZOLOMIDE1 in 1 CARTONCAPSULE18
59923-704-14TEMOZOLOMIDE14 in 1 BOTTLE, GLASSCAPSULE148

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59923-704-14EA - Each59923-704bb3b4178-9e0d-49d0-a108-2360e757aa7312019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59923-704TEMOZOLOMIDE CAPSULE [AREVA PHARMACEUTICALS]8Legacy NDC, 2 package rows20240203_7d4fb55d-4837-0ea4-e053-2a91aa0afe70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317160temozolomide 100 MG Oral CapsulePSN7d4fb55d-4837-0ea4-e053-2a91aa0afe708
700883temozolomide 140 MG Oral CapsulePSN7d4fb55d-4837-0ea4-e053-2a91aa0afe708
700885temozolomide 180 MG Oral CapsulePSN7d4fb55d-4837-0ea4-e053-2a91aa0afe708
313209temozolomide 20 MG Oral CapsulePSN7d4fb55d-4837-0ea4-e053-2a91aa0afe708
313210temozolomide 250 MG Oral CapsulePSN7d4fb55d-4837-0ea4-e053-2a91aa0afe708
313211temozolomide 5 MG Oral CapsulePSN7d4fb55d-4837-0ea4-e053-2a91aa0afe708
317160temozolomide 100 MG Oral CapsuleSCD7d4fb55d-4837-0ea4-e053-2a91aa0afe708
700883temozolomide 140 MG Oral CapsuleSCD7d4fb55d-4837-0ea4-e053-2a91aa0afe708
700885temozolomide 180 MG Oral CapsuleSCD7d4fb55d-4837-0ea4-e053-2a91aa0afe708
313209temozolomide 20 MG Oral CapsuleSCD7d4fb55d-4837-0ea4-e053-2a91aa0afe708
313210temozolomide 250 MG Oral CapsuleSCD7d4fb55d-4837-0ea4-e053-2a91aa0afe708
313211temozolomide 5 MG Oral CapsuleSCD7d4fb55d-4837-0ea4-e053-2a91aa0afe708

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59923-704-14599230704141 BOTTLE, GLASS in 1 CARTON (59923-704-14) > 14 CAPSULE in 1 BOTTLE, GLASS2019-01-250000-00-00NoNoCurrent