FDA.reportPublic FDA data

Temozolomide

Product NDC
16729-048
11-digit product format
167290048
Labeler code
16729
Product ID
16729-048_35ce99f0-8af9-4660-e063-6294a90a54bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA201528
Marketing category
ANDA
Marketing start
2017-03-07
Substance
TEMOZOLOMIDE
Active strength
5 mg/1
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Temozolomide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEMOZOLOMIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYF1K15M17Y
Rxcui313209, 313210, 313211, 317160, 700883, 700885

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-048-04Temozolomide1 in 1 POUCHCAPSULE110
16729-048-04Temozolomide14 in 1 CARTONCAPSULE1410
16729-048-31Temozolomide5 in 1 CARTONCAPSULE510
16729-048-31Temozolomide1 in 1 POUCHCAPSULE110
16729-048-53Temozolomide5 in 1 BOTTLE, GLASSCAPSULE510
16729-048-53Temozolomide1 in 1 CARTONCAPSULE110
16729-048-54Temozolomide1 in 1 CARTONCAPSULE110
16729-048-54Temozolomide14 in 1 BOTTLE, GLASSCAPSULE1410

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-048-53EA - Each16729-0481cc320f3-b430-4bdd-8e63-59e86eabc89d12017-04-05
16729-048-54EA - Each16729-0487764e4e3-2477-4a46-9f5f-387cfc72771812017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-048TEMOZOLOMIDE CAPSULE [ACCORD HEALTHCARE INC.]10Current NDC, Legacy NDC, 8 package rows20250524_2d599ccf-8e63-4ff1-aa52-4809744ea97a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317160temozolomide 100 MG Oral CapsulePSN2d599ccf-8e63-4ff1-aa52-4809744ea97a10
700883temozolomide 140 MG Oral CapsulePSN2d599ccf-8e63-4ff1-aa52-4809744ea97a10
700885temozolomide 180 MG Oral CapsulePSN2d599ccf-8e63-4ff1-aa52-4809744ea97a10
313209temozolomide 20 MG Oral CapsulePSN2d599ccf-8e63-4ff1-aa52-4809744ea97a10
313210temozolomide 250 MG Oral CapsulePSN2d599ccf-8e63-4ff1-aa52-4809744ea97a10
313211temozolomide 5 MG Oral CapsulePSN2d599ccf-8e63-4ff1-aa52-4809744ea97a10
317160temozolomide 100 MG Oral CapsuleSCD2d599ccf-8e63-4ff1-aa52-4809744ea97a10
700883temozolomide 140 MG Oral CapsuleSCD2d599ccf-8e63-4ff1-aa52-4809744ea97a10
700885temozolomide 180 MG Oral CapsuleSCD2d599ccf-8e63-4ff1-aa52-4809744ea97a10
313209temozolomide 20 MG Oral CapsuleSCD2d599ccf-8e63-4ff1-aa52-4809744ea97a10
313210temozolomide 250 MG Oral CapsuleSCD2d599ccf-8e63-4ff1-aa52-4809744ea97a10
313211temozolomide 5 MG Oral CapsuleSCD2d599ccf-8e63-4ff1-aa52-4809744ea97a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-048-04167290048041 in 1 POUCHHistorical
16729-048-31167290048315 in 1 CARTONHistorical
16729-048-53167290048531 BOTTLE, GLASS in 1 CARTON (16729-048-53) / 5 CAPSULE in 1 BOTTLE, GLASS2017-03-070000-00-00NoNoCurrent
16729-048-54167290048541 BOTTLE, GLASS in 1 CARTON (16729-048-54) / 14 CAPSULE in 1 BOTTLE, GLASS2017-03-070000-00-00NoNoCurrent