TEPYLUTE

Product NDC: 81927-105
11-digit product format: 819270105
Labeler code: 81927
Product ID: 81927-105_ea45bb79-9b31-48f4-9785-a94c3be6c1e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: thiotepa
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Shorla Oncology Inc.
Application: NDA216984
Marketing category: NDA
Marketing start: 2025-03-31
Substance: THIOTEPA
Active strength: 10 mg/mL
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
N216984-001	TEPYLUTE	THIOTEPA	15MG/1.5ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2024-06-25
N216984-002	TEPYLUTE	THIOTEPA	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2025-02-26

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216984-001	11975013	2041-08-16		Drug product	2024-07-25
N216984-001	12622921	2041-08-16	U-4530		2026-06-10
N216984-002	11975013	2041-08-16		Drug product	2025-03-07
N216984-002	12622921	2041-08-16	U-4530		2026-06-10

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N216984-001	TEPYLUTE	15MG/1.5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216984-002	TEPYLUTE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-02-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216984-001	TEPYLUTE	15MG/1.5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216984-002	TEPYLUTE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216984-001	TEPYLUTE	15MG/1.5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216984-002	TEPYLUTE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216984-001	TEPYLUTE	15MG/1.5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216984-002	TEPYLUTE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216984-001	TEPYLUTE	15MG/1.5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216984-001	TEPYLUTE	15MG/1.5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216984-001	TEPYLUTE	15MG/1.5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216984-001	TEPYLUTE	15MG/1.5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216984-001	TEPYLUTE	15MG/1.5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216984-001	TEPYLUTE	15MG/1.5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216984-001	TEPYLUTE	15MG/1.5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216984-001	TEPYLUTE	15MG/1.5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216984-001	TEPYLUTE	15MG/1.5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-06-25	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216984-001	TEPYLUTE	15MG/1.5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-06-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216984-002	TEPYLUTE	100MG/10ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-02-26	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N216984-001	11975013	2041-08-16		Drug product	2024-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216984-001	12622921	2041-08-16	U-4530		2026-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216984-002	11975013	2041-08-16		Drug product	2025-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216984-002	12622921	2041-08-16	U-4530		2026-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216984-001	11975013	2041-08-16		Drug product	2024-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216984-002	11975013	2041-08-16		Drug product	2025-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216984-001	11975013	2041-08-16		Drug product	2024-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216984-002	11975013	2041-08-16		Drug product	2025-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216984-001	11975013	2041-08-16		Drug product	2024-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216984-002	11975013	2041-08-16		Drug product	2025-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216984-001	11975013	2041-08-16		Drug product	2024-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216984-002	11975013	2041-08-16		Drug product	2025-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216984-001	11975013	2041-08-16		Drug product	2024-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216984-001	11975013	2041-08-16		Drug product	2024-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216984-001	11975013	2041-08-16		Drug product	2024-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216984-001	11975013	2041-08-16		Drug product	2024-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216984-001	11975013	2041-08-16		Drug product	2024-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216984-001	11975013	2041-08-16		Drug product	2024-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216984-001	11975013	2041-08-16		Drug product	2024-07-25	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216984-001	11975013	2041-08-16		Drug product	2024-07-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216984-001	12622921	2041-08-16	U-4530		2026-06-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216984-002	11975013	2041-08-16		Drug product	2025-03-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216984-002	12622921	2041-08-16	U-4530		2026-06-10	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: TEPYLUTE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
THIOTEPA	10 mg/mL

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2700709	Internal RxNorm lookup
2700712	Internal RxNorm lookup
2709440	Internal RxNorm lookup
2709442	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
add44e98-a042-4e38-b870-beb36693805b	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
81927-105-01	TEPYLUTE	1.5 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1.5		4
81927-105-01	TEPYLUTE	1 in 1 CARTON	INJECTION	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81927-105-01	ML - Milliliter	81927-105	416bf282-adcc-4e25-b10a-bce970546fe4	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81927-105	TEPYLUTE (THIOTEPA) INJECTION [SHORLA ONCOLOGY INC.]	3	Current NDC, 2 package rows	20250331_add44e98-a042-4e38-b870-beb36693805b.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
TEPYLUTE	THIOTEPA	Shorla Oncology Inc.	add44e98-a042-4e38-b870-beb36693805b	2025-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216984 application number: NDA216984 ndc (product): 81927-105

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
2709442	Tepylute 10 MG/ML Injectable Solution	PSN	add44e98-a042-4e38-b870-beb36693805b	4
2700712	Tepylute 15 MG in 1.5 ML Injection	PSN	add44e98-a042-4e38-b870-beb36693805b	4
2709440	thiotepa 10 MG/ML Injectable Solution	PSN	add44e98-a042-4e38-b870-beb36693805b	4
2700709	thiotepa 15 MG in 1.5 ML Injection	PSN	add44e98-a042-4e38-b870-beb36693805b	4
2700712	1.5 ML thiotepa 10 MG/ML Injection [Tepylute]	SBD	add44e98-a042-4e38-b870-beb36693805b	4
2709442	thiotepa 10 MG/ML Injectable Solution [Tepylute]	SBD	add44e98-a042-4e38-b870-beb36693805b	4
2700709	1.5 ML thiotepa 10 MG/ML Injection	SCD	add44e98-a042-4e38-b870-beb36693805b	4
2709440	thiotepa 10 MG/ML Injectable Solution	SCD	add44e98-a042-4e38-b870-beb36693805b	4
2700709	1.5 ML TSPA 10 MG/ML Injection	SY	add44e98-a042-4e38-b870-beb36693805b	4
2700712	1.5 ML TSPA 10 MG/ML Injection [Tepylute]	SY	add44e98-a042-4e38-b870-beb36693805b	4
2709442	Tepylute 10 MG per 1 ML Injectable Solution	SY	add44e98-a042-4e38-b870-beb36693805b	4
2700712	Tepylute 10 MG/ML per 1.5 ML Injection	SY	add44e98-a042-4e38-b870-beb36693805b	4
2700712	Tepylute 15 MG per 1.5 ML Injection	SY	add44e98-a042-4e38-b870-beb36693805b	4
2709440	thiotepa 10 MG per 1 ML Injectable Solution	SY	add44e98-a042-4e38-b870-beb36693805b	4
2700709	thiotepa 10 MG/ML per 1.5 ML Injection	SY	add44e98-a042-4e38-b870-beb36693805b	4
2700709	thiotepa 15 MG per 1.5 ML Injection	SY	add44e98-a042-4e38-b870-beb36693805b	4
2709440	TSPA 10 MG/ML Injectable Solution	SY	add44e98-a042-4e38-b870-beb36693805b	4
2709442	TSPA 10 MG/ML Injectable Solution [Tepylute]	SY	add44e98-a042-4e38-b870-beb36693805b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
81927-105-01	81927010501	1 VIAL, SINGLE-DOSE in 1 CARTON (81927-105-01) / 1.5 mL in 1 VIAL, SINGLE-DOSE	2025-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TEPYLUTE	Shorla Oncology Inc. \| Shorla Pharma Ltd. \| AqVida GmbH	2025-07-01	HUMAN PRESCRIPTION DRUG LABEL	4