TEMOZOLOMIDE

Product NDC
16571-819
11-digit product format
165710819
Labeler code
16571
Product ID
16571-819_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
140 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
A206309-001TEMOZOLOMIDETEMOZOLOMIDE5MGCAPSULE / ORALAB2016-04-27
A206309-002TEMOZOLOMIDETEMOZOLOMIDE20MGCAPSULE / ORALAB2016-04-27
A206309-003TEMOZOLOMIDETEMOZOLOMIDE100MGCAPSULE / ORALAB2016-04-27
A206309-004TEMOZOLOMIDETEMOZOLOMIDE140MGCAPSULE / ORALAB2016-04-27
A206309-005TEMOZOLOMIDETEMOZOLOMIDE180MGCAPSULE / ORALAB2016-04-27
A206309-006TEMOZOLOMIDETEMOZOLOMIDE250MGCAPSULE / ORALAB2016-04-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206309-001AB
A206309-002AB
A206309-003AB
A206309-004AB
A206309-005AB
A206309-006AB

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 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206309-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2016-04-27caaa826d4ba7…
2026-08-18 06:07:402026-07A206309-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2016-04-27caaa826d4ba7…
2026-08-18 06:07:402026-07A206309-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2016-04-27caaa826d4ba7…
2026-08-18 06:07:402026-07A206309-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2016-04-27caaa826d4ba7…
2026-08-18 06:07:402026-07A206309-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2016-04-27caaa826d4ba7…
2026-08-18 06:07:402026-07A206309-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2016-04-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206309-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2016-04-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206309-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2016-04-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206309-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2016-04-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206309-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2016-04-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206309-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2016-04-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206309-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2016-04-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206309-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2016-04-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206309-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2016-04-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206309-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2016-04-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206309-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2016-04-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206309-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2016-04-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206309-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2016-04-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A206309-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2016-04-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206309-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2016-04-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206309-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2016-04-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206309-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2016-04-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206309-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2016-04-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206309-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2016-04-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206309-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2016-04-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206309-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2016-04-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206309-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2016-04-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206309-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2016-04-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206309-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2016-04-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206309-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2016-04-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206309-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2016-04-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206309-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2016-04-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206309-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2016-04-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206309-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2016-04-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206309-005TEMOZOLOMIDE180MGCAPSULE / ORALAB2016-04-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206309-006TEMOZOLOMIDE250MGCAPSULE / ORALAB2016-04-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206309-001TEMOZOLOMIDE5MGCAPSULE / ORALAB2016-04-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206309-002TEMOZOLOMIDE20MGCAPSULE / ORALAB2016-04-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206309-003TEMOZOLOMIDE100MGCAPSULE / ORALAB2016-04-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206309-004TEMOZOLOMIDE140MGCAPSULE / ORALAB2016-04-2703ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A206309-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206309-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206309-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206309-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206309-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206309-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206309-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206309-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206309-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206309-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206309-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206309-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206309-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206309-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206309-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206309-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206309-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206309-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206309-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206309-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206309-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206309-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206309-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206309-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206309-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206309-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206309-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206309-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206309-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206309-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206309-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206309-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206309-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206309-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206309-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206309-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206309-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206309-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206309-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206309-004AB103ed91905a0d…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEMOZOLOMIDE140 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
70996a9d-4a4f-4ed1-ab07-130486aa14abAvailable 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
16571-819-02TEMOZOLOMIDE20 in 1 BOTTLECAPSULE206
16571-819-41TEMOZOLOMIDE14 in 1 BOTTLECAPSULE146
16571-819-51TEMOZOLOMIDE5 in 1 BOTTLECAPSULE56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-819-41EA - Each16571-819c5c7415e-eb33-4959-8d3e-72df78416b8212023-02-06
16571-819-51EA - Each16571-8196960f97a-acfe-4ac5-acc1-062132eb512312023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-819TEMOZOLOMIDE CAPSULE [RISING PHARMA HOLDINGS, INC.]6Current NDC, Legacy NDC, 3 package rows20240727_70996a9d-4a4f-4ed1-ab07-130486aa14ab.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
TEMOZOLOMIDETEMOZOLOMIDERising Pharma Holdings, Inc.70996a9d-4a4f-4ed1-ab07-130486aa14ab2024-07-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206309
application number: ANDA206309
ndc (product): 16571-819

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
16571-819-021657108190220 CAPSULE in 1 BOTTLE (16571-819-02) 20 capsule2022-10-040000-00-00NoNoCurrent
16571-819-411657108194114 CAPSULE in 1 BOTTLE (16571-819-41) 14 capsule2022-10-040000-00-00NoNoCurrent
16571-819-51165710819515 CAPSULE in 1 BOTTLE (16571-819-51) 5 capsule2022-10-040000-00-00NoNoCurrent