Home NDC 0143-9292 Thiotepa
Product NDC 0143-9292
11-digit product format 001439292
Labeler code 0143
Product ID 0143-9292_f18a13d2-83c0-42a1-8980-60b228c23ab9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Thiotepa
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA211755
Marketing category ANDA
Marketing start 2023-09-29
Substance THIOTEPA
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211755-001 THIOTEPA THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211755-001 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.
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 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211755-001 THIOTEPA 100MG/VIAL POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL AP 2023-09-05 a50c72e98297…
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 100 mg/1
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 1660004 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 0143-9292-01 Thiotepa 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 3 0143-9292-01 Thiotepa 1 in 1 BOX, UNIT-DOSE INJECTION, POWDER, LYOPHILIZED, 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9292 THIOTEPA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 3 Current NDC, 2 package rows 20230929_9ae8063c-ba28-4da2-a94c-8e1a5f75e4b3.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Thiotepa THIOTEPA Hikma Pharmaceuticals USA Inc. 9ae8063c-ba28-4da2-a94c-8e1a5f75e4b3 2023-05-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211755 application number: ANDA211755 ndc (product): 0143-9292
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0143-9292-01 00143929201 1 VIAL in 1 BOX, UNIT-DOSE (0143-9292-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 1 vial 2023-09-29 No No Current