FDA.reportPublic FDA data

Temozolomide

Product NDC
16729-050
11-digit product format
167290050
Labeler code
16729
Product ID
16729-050_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
100 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
TEMOZOLOMIDE100 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
16729-050-04Temozolomide14 in 1 CARTONCAPSULE1410
16729-050-04Temozolomide1 in 1 POUCHCAPSULE110
16729-050-31Temozolomide1 in 1 POUCHCAPSULE110
16729-050-31Temozolomide5 in 1 CARTONCAPSULE510
16729-050-53Temozolomide1 in 1 CARTONCAPSULE110
16729-050-53Temozolomide5 in 1 BOTTLE, GLASSCAPSULE510
16729-050-54Temozolomide1 in 1 CARTONCAPSULE110
16729-050-54Temozolomide14 in 1 BOTTLE, GLASSCAPSULE1410

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-050-53EA - Each16729-050ac03d21a-a17d-4b8f-adbf-c98b066dbbc512017-04-05
16729-050-54EA - Each16729-050fa3c2f04-0be4-4f64-aa6c-d225273e9a8612017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-050TEMOZOLOMIDE 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
16729-050-041672900500414 in 1 CARTONHistorical
16729-050-31167290050311 in 1 POUCHHistorical
16729-050-53167290050531 BOTTLE, GLASS in 1 CARTON (16729-050-53) / 5 CAPSULE in 1 BOTTLE, GLASS2017-03-070000-00-00NoNoCurrent
16729-050-54167290050541 BOTTLE, GLASS in 1 CARTON (16729-050-54) / 14 CAPSULE in 1 BOTTLE, GLASS2017-03-070000-00-00NoNoCurrent