Home NDC 70301-2005 Temozolomide
Product NDC 70301-2005
11-digit product format 703012005
Labeler code 70301
Product ID 70301-2005_5ca5ff09-bc92-d3ad-e063-6294a90a0fc8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TEMOZOLOMIDE
Dosage form CAPSULE
Route ORAL
Labeler OPKO Pharmaceuticals, LLC
Application ANDA203898
Marketing category ANDA
Marketing start 2026-09-16
Substance TEMOZOLOMIDE
Active strength 100 mg/1
Pharmacologic classes Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A203898-001 TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE / ORAL 2016-02-10 A203898-002 TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE / ORAL 2016-02-10 A203898-003 TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2016-02-10 A203898-004 TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2016-02-10 A203898-005 TEMOZOLOMIDE TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2016-02-10 A203898-006 TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2016-02-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 7 · 264 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 2026-10-15 13:18:30 2026-09 A203898-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL 2016-02-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203898-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL 2016-02-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203898-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2016-02-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203898-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2016-02-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203898-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2016-02-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203898-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2016-02-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 A203898-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL 2016-02-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203898-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL 2016-02-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203898-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2016-02-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203898-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2016-02-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203898-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2016-02-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203898-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2016-02-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203898-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL 2016-02-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203898-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL 2016-02-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203898-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2016-02-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203898-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2016-02-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203898-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2016-02-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203898-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2016-02-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203898-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL 2016-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203898-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL 2016-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203898-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2016-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203898-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2016-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203898-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2016-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203898-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2016-02-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203898-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL 2016-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203898-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL 2016-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203898-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2016-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203898-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2016-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203898-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2016-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203898-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2016-02-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203898-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL 2016-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203898-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL 2016-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203898-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2016-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203898-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2016-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203898-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2016-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203898-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2016-02-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203898-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL 2016-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203898-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL 2016-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203898-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL 2016-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203898-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL 2016-02-10 fd3edfee7708…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Temozolomide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TEMOZOLOMIDE 100 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70301-2005-1 Temozolomide 1 in 1 PACKET CAPSULE 1 2 70301-2005-1 Temozolomide 5 in 1 CARTON CAPSULE 5 2 70301-2005-2 Temozolomide 1 in 1 PACKET CAPSULE 1 2 70301-2005-2 Temozolomide 14 in 1 CARTON CAPSULE 14 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70301-2005-1 70301200501 5 PACKET in 1 CARTON (70301-2005-1) / 1 CAPSULE in 1 PACKET 5 packet 2026-09-16 No No Current 70301-2005-2 70301200502 14 PACKET in 1 CARTON (70301-2005-2) / 1 CAPSULE in 1 PACKET 14 packet 2026-09-16 No No Current