Thiotepa

Product NDC: 65219-029
11-digit product format: 652190029
Labeler code: 65219
Product ID: 65219-029_a1ce70f8-1f22-4771-b51a-2e9b12876558
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Thiotepa
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
Labeler: Fresenius Kabi USA, LLC
Application: ANDA214222
Marketing category: ANDA
Marketing start: 2022-04-11
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
A214222-001	THIOTEPA	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP		2021-03-08
A214222-002	THIOTEPA	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP		2022-01-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214222-001	AP
A214222-002	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 · 68 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	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214222-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2022-01-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214222-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2022-01-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214222-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2022-01-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214222-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2022-01-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214222-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2022-01-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214222-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2022-01-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214222-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2022-01-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214222-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2022-01-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214222-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2022-01-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214222-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2022-01-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214222-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2022-01-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214222-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2022-01-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214222-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2022-01-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214222-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2022-01-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214222-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2022-01-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214222-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2022-01-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214222-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2022-01-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214222-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2022-01-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214222-002	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2022-01-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214222-001	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	2021-03-08	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 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	A214222-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214222-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214222-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214222-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214222-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214222-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214222-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214222-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214222-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214222-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214222-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214222-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214222-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214222-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214222-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214222-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214222-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214222-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214222-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214222-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214222-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214222-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214222-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214222-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214222-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214222-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214222-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214222-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214222-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214222-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214222-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214222-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214222-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214222-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214222-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214222-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214222-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214222-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214222-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214222-001	AP	1	`87673890dc5c…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
493410f3-0733-4f76-8050-6529d96f2a5b	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
65219-029-20	Thiotepa	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		1
65219-029-20	Thiotepa	1 in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65219-029-20	EA - Each	65219-029	8bb53fe8-6082-47b2-b0ec-17c5b54089fe	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65219-029	THIOTEPA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1	Current NDC, Legacy NDC, 2 package rows	20220411_493410f3-0733-4f76-8050-6529d96f2a5b.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Thiotepa	THIOTEPA	Gland Pharma Limited	6cd6ae89-c553-4328-9262-4363610a1f19	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214222 application number: ANDA214222
Thiotepa	THIOTEPA	Dr.Reddy's Laboratories Inc.,	a8c8bb14-0423-e4a3-8bf0-8a66ce05b1bb	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214222 application number: ANDA214222
Thiotepa	THIOTEPA	Fresenius Kabi USA, LLC	493410f3-0733-4f76-8050-6529d96f2a5b	2022-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214222 application number: ANDA214222 ndc (product): 65219-029

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	493410f3-0733-4f76-8050-6529d96f2a5b	1
1660004	thiotepa 100 MG Injection	SCD	493410f3-0733-4f76-8050-6529d96f2a5b	1
1660004	TSPA 100 MG Injection	SY	493410f3-0733-4f76-8050-6529d96f2a5b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65219-029-20	65219002920	1 VIAL in 1 CARTON (65219-029-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL	1 vial	2022-04-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Thiotepa	Fresenius Kabi USA, LLC \| Gland Pharma Limited	2022-03-28	HUMAN PRESCRIPTION DRUG LABEL	1