Thiotepa

Product NDC: 72205-046
11-digit product format: 722050046
Labeler code: 72205
Product ID: 72205-046_fa8d1c84-357b-433d-8f78-89175c9a8cbc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Thiotepa
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
Labeler: Novadoz Pharmaceuticals LLC
Application: ANDA213049
Marketing category: ANDA
Marketing start: 2020-02-01
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213049-001	THIOTEPA	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP		2020-03-04
A213049-002	THIOTEPA	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP		2020-03-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A213049-001	AP
A213049-002	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 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213049-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213049-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2020-03-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213049-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213049-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213049-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213049-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213049-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213049-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213049-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213049-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213049-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213049-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213049-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213049-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213049-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213049-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213049-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213049-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213049-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213049-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213049-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213049-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213049-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213049-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213049-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213049-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213049-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213049-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213049-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213049-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213049-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213049-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213049-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213049-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213049-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213049-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213049-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213049-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213049-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213049-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213049-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213049-002	AP	1	`782e0a99824c…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1660004	Internal RxNorm lookup
1660009	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b702dcc9-dd0e-4386-b1e2-f20562fd2ad9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b9d03845-c04b-46cb-bb7e-9c6cffe3c163	Product name	4	20250618
d48e4a3f-d6a3-47a1-9357-dd5939f6049d	Product name	1	20250227
d4b5276b-261e-446e-ba03-7cf7bbc1d8af	Product name	3	20220718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72205-046-01	Thiotepa	1 in 1 BOX	INJECTION, POWDER, LYOPHILIZED,	1		2
72205-046-01	Thiotepa	1 in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72205-046-01	EA - Each	72205-046	c61a28ed-5e7a-4906-aa4d-fbf05f5ef5fe	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72205-046	THIOTEPA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADOZ PHARMACEUTICALS LLC]	2	Current NDC, Legacy NDC, 2 package rows	20250419_b702dcc9-dd0e-4386-b1e2-f20562fd2ad9.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	Novadoz Pharmaceuticals LLC	b702dcc9-dd0e-4386-b1e2-f20562fd2ad9	2024-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213049 application number: ANDA213049 ndc (product): 72205-046

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
905Z5W3GKH	THIOTEPA	52-24-4	THIOTEPA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1660004	thiotepa 100 MG Injection	PSN	b702dcc9-dd0e-4386-b1e2-f20562fd2ad9	2
1660009	thiotepa 15 MG Injection	PSN	b702dcc9-dd0e-4386-b1e2-f20562fd2ad9	2
1660004	thiotepa 100 MG Injection	SCD	b702dcc9-dd0e-4386-b1e2-f20562fd2ad9	2
1660009	thiotepa 15 MG Injection	SCD	b702dcc9-dd0e-4386-b1e2-f20562fd2ad9	2
1660004	TSPA 100 MG Injection	SY	b702dcc9-dd0e-4386-b1e2-f20562fd2ad9	2
1660009	TSPA 15 MG Injection	SY	b702dcc9-dd0e-4386-b1e2-f20562fd2ad9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72205-046-01	72205004601	1 VIAL, GLASS in 1 BOX (72205-046-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS	2020-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Thiotepa	Novadoz Pharmaceuticals LLC \| MSN LABORATORIES PRIVATE LIMITED	2024-04-14	Human Prescription Drug Label	2