TEMOZOLOMIDE

Product NDC
31722-413
11-digit product format
317220413
Labeler code
31722
Product ID
31722-413_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
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

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
A210030-001TEMOZOLOMIDETEMOZOLOMIDE5MGCAPSULE / ORALAB2024-08-23
A210030-002TEMOZOLOMIDETEMOZOLOMIDE20MGCAPSULE / ORALAB2024-08-23
A210030-003TEMOZOLOMIDETEMOZOLOMIDE100MGCAPSULE / ORALAB2024-08-23
A210030-004TEMOZOLOMIDETEMOZOLOMIDE140MGCAPSULE / ORALAB2024-08-23
A210030-005TEMOZOLOMIDETEMOZOLOMIDE180MGCAPSULE / ORALAB2024-08-23
A210030-006TEMOZOLOMIDETEMOZOLOMIDE250MGCAPSULE / ORALAB2024-08-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A210030-001AB
A210030-002AB
A210030-003AB
A210030-004AB
A210030-005AB
A210030-006AB

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 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210030-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2024-08-23caaa826d4ba7…
2026-08-18 06:07:402026-07A210030-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2024-08-23caaa826d4ba7…
2026-08-18 06:07:402026-07A210030-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2024-08-23caaa826d4ba7…
2026-08-18 06:07:402026-07A210030-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2024-08-23caaa826d4ba7…
2026-08-18 06:07:402026-07A210030-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2024-08-23caaa826d4ba7…
2026-08-18 06:07:402026-07A210030-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2024-08-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210030-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2024-08-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210030-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2024-08-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210030-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2024-08-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210030-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2024-08-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210030-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2024-08-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210030-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2024-08-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210030-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2024-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210030-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2024-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210030-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2024-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210030-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2024-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210030-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2024-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210030-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2024-08-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210030-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2024-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210030-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2024-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210030-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2024-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210030-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2024-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210030-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2024-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210030-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2024-08-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210030-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2024-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210030-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2024-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210030-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2024-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210030-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2024-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210030-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2024-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210030-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2024-08-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210030-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2024-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210030-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2024-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210030-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2024-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210030-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2024-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210030-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2024-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210030-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2024-08-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210030-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2024-08-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210030-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2024-08-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210030-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2024-08-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210030-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2024-08-2303ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210030-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210030-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210030-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210030-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210030-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210030-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210030-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210030-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210030-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210030-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210030-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210030-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210030-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210030-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210030-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210030-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210030-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210030-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210030-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210030-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210030-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210030-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210030-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210030-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210030-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210030-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210030-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210030-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210030-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210030-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210030-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210030-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210030-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210030-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210030-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210030-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210030-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210030-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210030-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210030-004AB103ed91905a0d…

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 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
78c12889-c837-40c1-8f85-4d048008ad29Available on FDA.report

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
31722-413-14TEMOZOLOMIDE14 in 1 BOTTLECAPSULE141
31722-413-31TEMOZOLOMIDE5 in 1 BOTTLECAPSULE51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-413-14EA - Each31722-413e5ca140d-e0ca-4be9-a457-530de925d4bf12025-03-04
31722-413-31EA - Each31722-41306409d04-f126-4fea-a60c-6f7a40a3e98e12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-413TEMOZOLOMIDE (TEMOZOLOMIDE) CAPSULE [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20241021_78c12889-c837-40c1-8f85-4d048008ad29.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
TEMOZOLOMIDETEMOZOLOMIDECamber Pharmaceuticals, Inc.78c12889-c837-40c1-8f85-4d048008ad292024-10-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210030
application number: ANDA210030
ndc (product): 31722-413

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
31722-413-143172204131414 CAPSULE in 1 BOTTLE (31722-413-14) 14 capsule2024-08-23NoNoCurrent
31722-413-31317220413315 CAPSULE in 1 BOTTLE (31722-413-31) 5 capsule2024-08-23NoNoCurrent