Home NDC 0143-9309 Thiotepa
Product NDC 0143-9309
11-digit product format 001439309
Labeler code 0143
Product ID 0143-9309_43ac39a1-a0e0-48e9-93e2-e7e754bc6038
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Thiotepa
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA075547
Marketing category ANDA
Marketing start 2001-06-01
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 A075547-001 THIOTEPA THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075547-001 AP
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 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075547-001 THIOTEPA 15MG/VIAL INJECTABLE / INJECTION AP RS 2001-04-02 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 0143-9309-01 Thiotepa 1.5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1.5 4 0143-9309-01 Thiotepa 1 in 1 BOX, UNIT-DOSE INJECTION, POWDER, LYOPHILIZED, 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9309 THIOTEPA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 4 Current NDC, Legacy NDC, 2 package rows 20230525_6dc898dc-5949-4aa4-83f8-4bd20c29eb93.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 · 2 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 0143-9309-01 00143930901 1 VIAL in 1 BOX, UNIT-DOSE (0143-9309-01) / 1.5 mL in 1 VIAL 1 vial 2001-06-01 0000-00-00 No No Current