temozolomide

Product NDC
75834-145
11-digit product format
758340145
Labeler code
75834
Product ID
75834-145_9db23336-458a-46a6-a676-1702497a1891
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA213328
Marketing category
ANDA
Marketing start
2021-12-07
Substance
TEMOZOLOMIDE
Active strength
180 mg/1
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213328-001TEMOZOLOMIDETEMOZOLOMIDE5MGCAPSULE / ORAL2021-11-23
A213328-002TEMOZOLOMIDETEMOZOLOMIDE20MGCAPSULE / ORAL2021-11-23
A213328-003TEMOZOLOMIDETEMOZOLOMIDE100MGCAPSULE / ORAL2021-11-23
A213328-004TEMOZOLOMIDETEMOZOLOMIDE140MGCAPSULE / ORAL2021-11-23
A213328-005TEMOZOLOMIDETEMOZOLOMIDE180MGCAPSULE / ORAL2021-11-23
A213328-006TEMOZOLOMIDETEMOZOLOMIDE250MGCAPSULE / ORAL2021-11-23

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 6 · 204 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A213328-001TEMOZOLOMIDE5MGCAPSULE / ORAL2021-11-23caaa826d4ba7…
2026-08-18 06:07:402026-07A213328-002TEMOZOLOMIDE20MGCAPSULE / ORAL2021-11-23caaa826d4ba7…
2026-08-18 06:07:402026-07A213328-003TEMOZOLOMIDE100MGCAPSULE / ORAL2021-11-23caaa826d4ba7…
2026-08-18 06:07:402026-07A213328-004TEMOZOLOMIDE140MGCAPSULE / ORAL2021-11-23caaa826d4ba7…
2026-08-18 06:07:402026-07A213328-005TEMOZOLOMIDE180MGCAPSULE / ORAL2021-11-23caaa826d4ba7…
2026-08-18 06:07:402026-07A213328-006TEMOZOLOMIDE250MGCAPSULE / ORAL2021-11-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213328-001TEMOZOLOMIDE5MGCAPSULE / ORAL2021-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213328-002TEMOZOLOMIDE20MGCAPSULE / ORAL2021-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213328-003TEMOZOLOMIDE100MGCAPSULE / ORAL2021-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213328-004TEMOZOLOMIDE140MGCAPSULE / ORAL2021-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213328-005TEMOZOLOMIDE180MGCAPSULE / ORAL2021-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213328-006TEMOZOLOMIDE250MGCAPSULE / ORAL2021-11-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213328-001TEMOZOLOMIDE5MGCAPSULE / ORAL2021-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213328-002TEMOZOLOMIDE20MGCAPSULE / ORAL2021-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213328-003TEMOZOLOMIDE100MGCAPSULE / ORAL2021-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213328-004TEMOZOLOMIDE140MGCAPSULE / ORAL2021-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213328-005TEMOZOLOMIDE180MGCAPSULE / ORAL2021-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213328-006TEMOZOLOMIDE250MGCAPSULE / ORAL2021-11-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A213328-001TEMOZOLOMIDE5MGCAPSULE / ORAL2021-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213328-002TEMOZOLOMIDE20MGCAPSULE / ORAL2021-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213328-003TEMOZOLOMIDE100MGCAPSULE / ORAL2021-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213328-004TEMOZOLOMIDE140MGCAPSULE / ORAL2021-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213328-005TEMOZOLOMIDE180MGCAPSULE / ORAL2021-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213328-006TEMOZOLOMIDE250MGCAPSULE / ORAL2021-11-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213328-001TEMOZOLOMIDE5MGCAPSULE / ORAL2021-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213328-002TEMOZOLOMIDE20MGCAPSULE / ORAL2021-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213328-003TEMOZOLOMIDE100MGCAPSULE / ORAL2021-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213328-004TEMOZOLOMIDE140MGCAPSULE / ORAL2021-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213328-005TEMOZOLOMIDE180MGCAPSULE / ORAL2021-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213328-006TEMOZOLOMIDE250MGCAPSULE / ORAL2021-11-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213328-001TEMOZOLOMIDE5MGCAPSULE / ORAL2021-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213328-002TEMOZOLOMIDE20MGCAPSULE / ORAL2021-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213328-003TEMOZOLOMIDE100MGCAPSULE / ORAL2021-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213328-004TEMOZOLOMIDE140MGCAPSULE / ORAL2021-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213328-005TEMOZOLOMIDE180MGCAPSULE / ORAL2021-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213328-006TEMOZOLOMIDE250MGCAPSULE / ORAL2021-11-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213328-001TEMOZOLOMIDE5MGCAPSULE / ORAL2021-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213328-002TEMOZOLOMIDE20MGCAPSULE / ORAL2021-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213328-003TEMOZOLOMIDE100MGCAPSULE / ORAL2021-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213328-004TEMOZOLOMIDE140MGCAPSULE / ORAL2021-11-2303ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 138 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213328-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213328-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213328-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213328-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213328-005AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213328-006AB15bbf6a4d5a75…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213328-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213328-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213328-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213328-004AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213328-005AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213328-006AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213328-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213328-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213328-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213328-004AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213328-005AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213328-006AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213328-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213328-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213328-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213328-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213328-005AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213328-006AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213328-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213328-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213328-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213328-004AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213328-005AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213328-006AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213328-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213328-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213328-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213328-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213328-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213328-006AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213328-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213328-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213328-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213328-004AB15d02ea3f76ae…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEMOZOLOMIDE180 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YF1K15M17YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313209Internal RxNorm lookup
313210Internal RxNorm lookup
313211Internal RxNorm lookup
317160Internal RxNorm lookup
700883Internal RxNorm lookup
700885Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
27e5a781-e4f2-4489-9def-7971d0b86d9cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
3afbbf09-a1e0-475e-b654-466d26d19d69Product name920170706

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-145-05temozolomide5 in 1 CARTONCAPSULE55
75834-145-05temozolomide1 in 1 CARTONCAPSULE15
75834-145-14temozolomide14 in 1 CARTONCAPSULE145
75834-145-14temozolomide1 in 1 CARTONCAPSULE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-145-05EA - Each75834-145f1cae5a8-c9bd-4af8-b75e-2d1eac13412912022-01-06
75834-145-14EA - Each75834-145c33bebe0-c124-4971-9bd3-67d11755db3e12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-145TEMOZOLOMIDE CAPSULE [NIVAGEN PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 4 package rows20211207_27e5a781-e4f2-4489-9def-7971d0b86d9c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
temozolomideTEMOZOLOMIDENivagen Pharmaceuticals, Inc.27e5a781-e4f2-4489-9def-7971d0b86d9c2021-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213328
application number: ANDA213328
ndc (product): 75834-145

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317160temozolomide 100 MG Oral CapsulePSN27e5a781-e4f2-4489-9def-7971d0b86d9c5
700883temozolomide 140 MG Oral CapsulePSN27e5a781-e4f2-4489-9def-7971d0b86d9c5
700885temozolomide 180 MG Oral CapsulePSN27e5a781-e4f2-4489-9def-7971d0b86d9c5
313209temozolomide 20 MG Oral CapsulePSN27e5a781-e4f2-4489-9def-7971d0b86d9c5
313210temozolomide 250 MG Oral CapsulePSN27e5a781-e4f2-4489-9def-7971d0b86d9c5
313211temozolomide 5 MG Oral CapsulePSN27e5a781-e4f2-4489-9def-7971d0b86d9c5
317160temozolomide 100 MG Oral CapsuleSCD27e5a781-e4f2-4489-9def-7971d0b86d9c5
700883temozolomide 140 MG Oral CapsuleSCD27e5a781-e4f2-4489-9def-7971d0b86d9c5
700885temozolomide 180 MG Oral CapsuleSCD27e5a781-e4f2-4489-9def-7971d0b86d9c5
313209temozolomide 20 MG Oral CapsuleSCD27e5a781-e4f2-4489-9def-7971d0b86d9c5
313210temozolomide 250 MG Oral CapsuleSCD27e5a781-e4f2-4489-9def-7971d0b86d9c5
313211temozolomide 5 MG Oral CapsuleSCD27e5a781-e4f2-4489-9def-7971d0b86d9c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-145-05758340145051 CARTON in 1 CARTON (75834-145-05) / 5 CAPSULE in 1 CARTON1 carton2021-12-070000-00-00NoNoCurrent
75834-145-14758340145141 CARTON in 1 CARTON (75834-145-14) / 14 CAPSULE in 1 CARTON1 carton2021-12-070000-00-00NoNoCurrent