FDA.reportPublic FDA data

Temozolomide

Product NDC
67877-537
11-digit product format
678770537
Labeler code
67877
Product ID
67877-537_f519f4f0-bb62-43cb-bfc2-15f00ac1aad3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA207658
Marketing category
ANDA
Marketing start
2017-04-28
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67877-537-072023-03-21C16284748780-1ba0f9c33-4a5b-a910-e053-dadaa90a0b85These 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 for oral use Initial U.S. Approval: 1999
67877-537-142023-03-21C16284748780-1ba0f9c33-4a5b-a910-e053-dadaa90a0b85These 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 for oral use Initial U.S. Approval: 1999
67877-537-072023-01-30C16284748780-1ba0f9c33-4a5b-a910-e053-dadaa90a0b85These 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 for oral use Initial U.S. Approval: 1999
67877-537-142023-01-30C16284748780-1ba0f9c33-4a5b-a910-e053-dadaa90a0b85These 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 for oral use Initial U.S. Approval: 1999
67877-537-072021-07-09C16284748780-1ba0f9c33-4a5b-a910-e053-dadaa90a0b85These 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 for oral use Initial U.S. Approval: 1999
67877-537-142021-07-09C16284748780-1ba0f9c33-4a5b-a910-e053-dadaa90a0b85These 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 for oral use Initial U.S. Approval: 1999
67877-537-072021-01-29C16284748780-1ba0f9c33-4a5b-a910-e053-dadaa90a0b85These 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 for oral use Initial U.S. Approval: 1999
67877-537-142021-01-29C16284748780-1ba0f9c33-4a5b-a910-e053-dadaa90a0b85These 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 for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-537-07Temozolomide5 in 1 BOTTLECAPSULE59
67877-537-14Temozolomide14 in 1 BOTTLECAPSULE149

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-537-07EA - Each67877-537a32c6532-2fd5-4dfa-b61a-575bbfc19e0a12017-12-14
67877-537-14EA - Each67877-537c19cef19-023b-4c7b-8d57-a2a6bad3425712017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-537TEMOZOLOMIDE CAPSULE [ASCEND LABORATORIES, LLC]9Current NDC, Legacy NDC, 2 package rows20250112_33d67bce-38ae-45fc-a858-d51167b0ecfd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317160temozolomide 100 MG Oral CapsulePSN33d67bce-38ae-45fc-a858-d51167b0ecfd9
700883temozolomide 140 MG Oral CapsulePSN33d67bce-38ae-45fc-a858-d51167b0ecfd9
700885temozolomide 180 MG Oral CapsulePSN33d67bce-38ae-45fc-a858-d51167b0ecfd9
313209temozolomide 20 MG Oral CapsulePSN33d67bce-38ae-45fc-a858-d51167b0ecfd9
313210temozolomide 250 MG Oral CapsulePSN33d67bce-38ae-45fc-a858-d51167b0ecfd9
313211temozolomide 5 MG Oral CapsulePSN33d67bce-38ae-45fc-a858-d51167b0ecfd9
317160temozolomide 100 MG Oral CapsuleSCD33d67bce-38ae-45fc-a858-d51167b0ecfd9
700883temozolomide 140 MG Oral CapsuleSCD33d67bce-38ae-45fc-a858-d51167b0ecfd9
700885temozolomide 180 MG Oral CapsuleSCD33d67bce-38ae-45fc-a858-d51167b0ecfd9
313209temozolomide 20 MG Oral CapsuleSCD33d67bce-38ae-45fc-a858-d51167b0ecfd9
313210temozolomide 250 MG Oral CapsuleSCD33d67bce-38ae-45fc-a858-d51167b0ecfd9
313211temozolomide 5 MG Oral CapsuleSCD33d67bce-38ae-45fc-a858-d51167b0ecfd9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-537-07678770537075 CAPSULE in 1 BOTTLE (67877-537-07) 5 capsule2017-04-280000-00-00NoNoCurrent
67877-537-146787705371414 CAPSULE in 1 BOTTLE (67877-537-14) 14 capsule2017-04-280000-00-00NoNoCurrent