FDA.reportPublic FDA data

TEMOZOLOMIDE

Product NDC
16571-821
11-digit product format
165710821
Labeler code
16571
Product ID
16571-821_b75f958e-33bc-434d-a4ae-e5fa9d6f4ab5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA206309
Marketing category
ANDA
Marketing start
2022-10-04
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
16571-821-02TEMOZOLOMIDE20 in 1 BOTTLECAPSULE206
16571-821-51TEMOZOLOMIDE5 in 1 BOTTLECAPSULE56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-821-51EA - Each16571-821b0d2e1d1-f45c-4e49-a39c-48bfc42c604212023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-821TEMOZOLOMIDE CAPSULE [RISING PHARMA HOLDINGS, INC.]6Current NDC, Legacy NDC, 2 package rows20240727_70996a9d-4a4f-4ed1-ab07-130486aa14ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317160temozolomide 100 MG Oral CapsulePSN70996a9d-4a4f-4ed1-ab07-130486aa14ab6
700883temozolomide 140 MG Oral CapsulePSN70996a9d-4a4f-4ed1-ab07-130486aa14ab6
700885temozolomide 180 MG Oral CapsulePSN70996a9d-4a4f-4ed1-ab07-130486aa14ab6
313209temozolomide 20 MG Oral CapsulePSN70996a9d-4a4f-4ed1-ab07-130486aa14ab6
313210temozolomide 250 MG Oral CapsulePSN70996a9d-4a4f-4ed1-ab07-130486aa14ab6
313211temozolomide 5 MG Oral CapsulePSN70996a9d-4a4f-4ed1-ab07-130486aa14ab6
317160temozolomide 100 MG Oral CapsuleSCD70996a9d-4a4f-4ed1-ab07-130486aa14ab6
700883temozolomide 140 MG Oral CapsuleSCD70996a9d-4a4f-4ed1-ab07-130486aa14ab6
700885temozolomide 180 MG Oral CapsuleSCD70996a9d-4a4f-4ed1-ab07-130486aa14ab6
313209temozolomide 20 MG Oral CapsuleSCD70996a9d-4a4f-4ed1-ab07-130486aa14ab6
313210temozolomide 250 MG Oral CapsuleSCD70996a9d-4a4f-4ed1-ab07-130486aa14ab6
313211temozolomide 5 MG Oral CapsuleSCD70996a9d-4a4f-4ed1-ab07-130486aa14ab6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-821-021657108210220 CAPSULE in 1 BOTTLE (16571-821-02) 20 capsule2022-10-040000-00-00NoNoCurrent
16571-821-411657108214114 CAPSULE in 1 BOTTLE (16571-821-41) 14 capsule2022-10-040000-00-00NoNoCurrent
16571-821-51165710821515 CAPSULE in 1 BOTTLE (16571-821-51) 5 capsule2022-10-040000-00-00NoNoCurrent