Home NDC 31722-412 TEMOZOLOMIDE
Product NDC 31722-412
11-digit product format 317220412
Labeler code 31722
Product ID 31722-412_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 20 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210030-001 TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2024-08-23 A210030-002 TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2024-08-23 A210030-003 TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2024-08-23 A210030-004 TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2024-08-23 A210030-005 TEMOZOLOMIDE TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2024-08-23 A210030-006 TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2024-08-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A210030-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2024-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210030-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2024-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210030-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2024-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210030-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2024-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210030-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2024-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210030-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2024-08-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210030-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2024-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210030-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2024-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210030-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2024-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210030-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2024-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210030-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2024-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210030-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2024-08-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210030-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2024-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210030-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2024-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210030-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2024-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210030-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2024-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210030-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2024-08-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210030-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2024-08-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210030-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2024-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210030-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2024-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210030-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2024-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210030-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2024-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210030-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2024-08-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210030-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2024-08-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210030-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2024-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210030-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2024-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210030-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2024-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210030-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2024-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210030-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2024-08-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210030-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2024-08-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210030-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2024-08-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210030-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2024-08-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210030-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2024-08-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210030-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2024-08-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210030-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2024-08-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210030-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2024-08-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210030-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2024-08-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210030-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2024-08-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210030-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2024-08-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210030-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2024-08-23 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
Additional Listing Data#
Finished product Yes
Brand name base TEMOZOLOMIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TEMOZOLOMIDE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YF1K15M17Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313209 Internal RxNorm lookup 313210 Internal RxNorm lookup 313211 Internal RxNorm lookup 317160 Internal RxNorm lookup 700883 Internal RxNorm lookup 700885 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 31722-412-14 TEMOZOLOMIDE 14 in 1 BOTTLE CAPSULE 14 1 31722-412-31 TEMOZOLOMIDE 5 in 1 BOTTLE CAPSULE 5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-412 TEMOZOLOMIDE (TEMOZOLOMIDE) CAPSULE [CAMBER PHARMACEUTICALS, INC.] 1 Current NDC, 2 package rows 20241021_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 31722-412-14 31722041214 14 CAPSULE in 1 BOTTLE (31722-412-14) 14 capsule 2024-08-23 No No Current 31722-412-31 31722041231 5 CAPSULE in 1 BOTTLE (31722-412-31) 5 capsule 2024-08-23 No No Current