Home NDC 25021-246 Thiotepa
Product NDC 25021-246
11-digit product format 250210246
Labeler code 25021
Product ID 25021-246_94e38a38-8923-499d-bd75-f85754d7c730
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Thiotepa
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
Labeler Sagent Pharmaceuticals
Application ANDA209150
Marketing category ANDA
Marketing start 2018-06-15
Substance THIOTEPA
Active strength 15 mg/1.5mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209150-001 THIOTEPA THIOTEPA 15MG/VIAL INJECTABLE / INJECTION 2018-05-04
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 · 42 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 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION 2018-05-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209150-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP 2018-05-04 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Thiotepa
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength THIOTEPA 15 mg/1.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905Z5W3GKH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1660009 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 25021-246-02 Thiotepa 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 4 25021-246-02 Thiotepa 1.5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1.5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-246 THIOTEPA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] 3 Current NDC, Legacy NDC, 2 package rows 20210819_448c29f1-6d9c-4f8e-8a69-9b85e973e728.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 25021-246-02 25021024602 1 VIAL in 1 CARTON (25021-246-02) / 1.5 mL in 1 VIAL 1 vial 2018-06-15 0000-00-00 No No Current