Home NDC 65162-803 Temozolomide
Product NDC 65162-803
11-digit product format 651620803
Labeler code 65162
Product ID 65162-803_7cf62d84-45c0-405c-975b-3dbcbcf5ee27
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Temozolomide
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA203691
Marketing category ANDA
Marketing start 2015-04-03
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203691-001 TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2015-05-08 A203691-002 TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2015-05-08 A203691-003 TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2015-05-08 A203691-004 TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2015-05-08 A203691-005 TEMOZOLOMIDE TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2015-05-08 A203691-006 TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE / ORAL AB RS 2015-05-08
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 7 · 252 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 A203691-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2015-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203691-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2015-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203691-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2015-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203691-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2015-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203691-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2015-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203691-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB RS 2015-05-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203691-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2015-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203691-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2015-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203691-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2015-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203691-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2015-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203691-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2015-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203691-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB RS 2015-05-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203691-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2015-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203691-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2015-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203691-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2015-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203691-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2015-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203691-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2015-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203691-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB RS 2015-05-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203691-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2015-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203691-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2015-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203691-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2015-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203691-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2015-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203691-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2015-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203691-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB RS 2015-05-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203691-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2015-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203691-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2015-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203691-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2015-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203691-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2015-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203691-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2015-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203691-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB RS 2015-05-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203691-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2015-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203691-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2015-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203691-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2015-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203691-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2015-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203691-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2015-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203691-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB RS 2015-05-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203691-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2015-05-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203691-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2015-05-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203691-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2015-05-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203691-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2015-05-08 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 252 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 100 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 65162-803-14 Temozolomide 1 in 1 CARTON CAPSULE 1 26 65162-803-14 Temozolomide 14 in 1 BOTTLE CAPSULE 14 26 65162-803-51 Temozolomide 1 in 1 CARTON CAPSULE 1 26 65162-803-51 Temozolomide 5 in 1 BOTTLE CAPSULE 5 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TEMOZOLOMIDE ACTIVE INGREDIENT YF1K15M17Y TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 TEMOZOLOMIDE ACTIVE MOIETY YF1K15M17Y TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 ALCOHOL INACTIVE INGREDIENT 3K9958V90M TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 GELATIN INACTIVE INGREDIENT 2G86QN327L TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 SHELLAC INACTIVE INGREDIENT 46N107B71O TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 TARTARIC ACID INACTIVE INGREDIENT W4888I119H TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-803 TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS LLC] 26 Current NDC, Legacy NDC, 4 package rows 20250124_6c8529ec-8936-4fec-a1a5-2b285c7e4859.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 Marketing end Sample Exclude flag Status 65162-803-14 65162080314 1 BOTTLE in 1 CARTON (65162-803-14) / 14 CAPSULE in 1 BOTTLE 1 bottle 2015-04-03 0000-00-00 No No Current 65162-803-51 65162080351 1 BOTTLE in 1 CARTON (65162-803-51) / 5 CAPSULE in 1 BOTTLE 1 bottle 2015-04-03 0000-00-00 No No Current