Home NDC 47335-930 Temozolomide
Product NDC 47335-930
11-digit product format 473350930
Labeler code 47335
Product ID 47335-930_7c774570-443b-40da-8038-7cb550f92048
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Temozolomide
Dosage form CAPSULE
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA201742
Marketing category ANDA
Marketing start 2014-02-13
Substance TEMOZOLOMIDE
Active strength 180 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 A201742-001 TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2014-02-12 A201742-002 TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2014-02-12 A201742-003 TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2014-02-12 A201742-004 TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2014-02-12 A201742-005 TEMOZOLOMIDE TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2014-02-12 A201742-006 TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2014-02-12
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 A201742-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2014-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201742-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2014-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201742-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2014-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201742-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2014-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201742-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2014-02-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201742-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2014-02-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201742-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2014-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201742-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2014-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201742-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2014-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201742-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2014-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201742-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2014-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201742-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2014-02-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201742-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2014-02-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201742-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2014-02-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201742-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2014-02-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201742-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2014-02-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201742-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2014-02-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201742-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2014-02-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201742-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2014-02-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201742-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2014-02-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201742-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2014-02-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201742-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2014-02-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201742-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2014-02-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201742-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2014-02-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201742-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2014-02-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201742-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2014-02-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201742-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2014-02-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201742-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2014-02-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201742-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2014-02-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201742-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2014-02-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201742-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2014-02-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201742-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2014-02-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201742-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2014-02-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201742-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2014-02-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201742-005 TEMOZOLOMIDE 180MG CAPSULE / ORAL AB 2014-02-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201742-006 TEMOZOLOMIDE 250MG CAPSULE / ORAL AB 2014-02-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201742-001 TEMOZOLOMIDE 5MG CAPSULE / ORAL AB 2014-02-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201742-002 TEMOZOLOMIDE 20MG CAPSULE / ORAL AB 2014-02-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201742-003 TEMOZOLOMIDE 100MG CAPSULE / ORAL AB 2014-02-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201742-004 TEMOZOLOMIDE 140MG CAPSULE / ORAL AB 2014-02-12 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 180 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# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47335-930 TEMOZOLOMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] 23 Current NDC, Legacy NDC, 12 package rows 20231013_c1e05c21-a411-4493-80de-ede373632475.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 47335-930-21 47335093021 1 BOTTLE in 1 CARTON (47335-930-21) / 14 CAPSULE in 1 BOTTLE 1 bottle 2014-02-13 0000-00-00 No No Current 47335-930-72 47335093072 15 BLISTER PACK in 1 CARTON (47335-930-72) / 1 CAPSULE in 1 BLISTER PACK 15 blister pack 2014-02-13 0000-00-00 No No Current 47335-930-74 47335093074 5 BLISTER PACK in 1 CARTON (47335-930-74) / 1 CAPSULE in 1 BLISTER PACK 5 blister pack 2014-02-13 0000-00-00 No No Current 47335-930-75 47335093075 20 BLISTER PACK in 1 CARTON (47335-930-75) / 1 CAPSULE in 1 BLISTER PACK 20 blister pack 2014-02-13 0000-00-00 No No Current 47335-930-80 47335093080 1 BOTTLE in 1 CARTON (47335-930-80) / 5 CAPSULE in 1 BOTTLE 1 bottle 2014-02-13 0000-00-00 No No Current 47335-930-87 47335093087 1 BOTTLE in 1 CARTON (47335-930-87) / 20 CAPSULE in 1 BOTTLE 1 bottle 2014-02-13 0000-00-00 No No Current