FDA.reportPublic FDA data

TEMOZOLOMIDE

Product NDC
31722-416
11-digit product format
317220416
Labeler code
31722
Product ID
31722-416_24d38de8-4acf-bdac-e063-6394a90ad431
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TEMOZOLOMIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA210030
Marketing category
ANDA
Marketing start
2024-08-23
Substance
TEMOZOLOMIDE
Active strength
250 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
TEMOZOLOMIDE250 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
31722-416-14TEMOZOLOMIDE14 in 1 BOTTLECAPSULE141
31722-416-31TEMOZOLOMIDE5 in 1 BOTTLECAPSULE51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-416-31EA - Each31722-41666431c1c-d023-4cd8-bac3-59acbf66f79212025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-416TEMOZOLOMIDE (TEMOZOLOMIDE) CAPSULE [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20241021_78c12889-c837-40c1-8f85-4d048008ad29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317160temozolomide 100 MG Oral CapsulePSN78c12889-c837-40c1-8f85-4d048008ad291
700883temozolomide 140 MG Oral CapsulePSN78c12889-c837-40c1-8f85-4d048008ad291
700885temozolomide 180 MG Oral CapsulePSN78c12889-c837-40c1-8f85-4d048008ad291
313209temozolomide 20 MG Oral CapsulePSN78c12889-c837-40c1-8f85-4d048008ad291
313210temozolomide 250 MG Oral CapsulePSN78c12889-c837-40c1-8f85-4d048008ad291
313211temozolomide 5 MG Oral CapsulePSN78c12889-c837-40c1-8f85-4d048008ad291
317160temozolomide 100 MG Oral CapsuleSCD78c12889-c837-40c1-8f85-4d048008ad291
700883temozolomide 140 MG Oral CapsuleSCD78c12889-c837-40c1-8f85-4d048008ad291
700885temozolomide 180 MG Oral CapsuleSCD78c12889-c837-40c1-8f85-4d048008ad291
313209temozolomide 20 MG Oral CapsuleSCD78c12889-c837-40c1-8f85-4d048008ad291
313210temozolomide 250 MG Oral CapsuleSCD78c12889-c837-40c1-8f85-4d048008ad291
313211temozolomide 5 MG Oral CapsuleSCD78c12889-c837-40c1-8f85-4d048008ad291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-416-143172204161414 CAPSULE in 1 BOTTLE (31722-416-14) 14 capsule2024-08-23NoNoHistorical
31722-416-31317220416315 CAPSULE in 1 BOTTLE (31722-416-31) 5 capsule2024-08-23NoNoHistorical