TEPADINA

Product NDC: 70121-1631
11-digit product format: 701211631
Labeler code: 70121
Product ID: 70121-1631_4f44c872-f02d-48cc-b2a4-4e05d2422b72
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: THIOTEPA
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRACAVITARY; INTRAVENOUS; INTRAVESICAL
Labeler: Amneal Pharmaceuticals LLC
Application: NDA208264
Marketing category: NDA
Marketing start: 2017-08-15
Substance: THIOTEPA
Active strength: 100 mg/1
Pharmacologic classes: Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208264-001	TEPADINA	THIOTEPA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26
N208264-002	TEPADINA	THIOTEPA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26
N208264-003	TEPADINA AND SODIUM CHLORIDE	THIOTEPA	200MG	POWDER / INTRAVENOUS		RLD, RS	2025-04-10
N208264-004	TEPADINA AND SODIUM CHLORIDE	THIOTEPA	400MG	POWDER / INTRAVENOUS		RLD, RS	2026-01-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208264-001	AP
N208264-002	AP

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208264-003	9931458	2037-05-31		Drug product	2025-05-09
N208264-004	9931458	2037-05-31		Drug product	2026-02-12

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 3 · 92 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	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208264-003	TEPADINA AND SODIUM CHLORIDE	200MG	POWDER / INTRAVENOUS		RLD, RS	2025-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208264-004	TEPADINA AND SODIUM CHLORIDE	400MG	POWDER / INTRAVENOUS		RLD, RS	2026-01-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208264-003	TEPADINA AND SODIUM CHLORIDE	200MG	POWDER / INTRAVENOUS		RLD, RS	2025-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208264-004	TEPADINA AND SODIUM CHLORIDE	400MG	POWDER / INTRAVENOUS		RLD, RS	2026-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208264-003	TEPADINA AND SODIUM CHLORIDE	200MG	POWDER / INTRAVENOUS		RLD, RS	2025-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208264-003	TEPADINA AND SODIUM CHLORIDE	200MG	POWDER / INTRAVENOUS		RLD, RS	2025-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208264-001	TEPADINA	15MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208264-002	TEPADINA	100MG/VIAL	POWDER / INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	AP	RLD, RS	2017-01-26	`5d02ea3f76ae…`

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	N208264-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208264-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208264-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208264-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208264-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208264-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208264-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208264-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208264-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208264-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208264-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208264-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208264-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208264-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208264-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208264-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208264-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208264-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208264-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208264-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208264-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208264-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208264-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208264-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208264-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208264-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208264-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208264-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208264-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208264-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208264-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208264-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208264-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208264-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208264-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208264-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208264-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208264-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208264-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208264-002	AP	1	`782e0a99824c…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208264-003	9931458	2037-05-31	Drug product	2025-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208264-004	9931458	2037-05-31	Drug product	2026-02-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208264-003	9931458	2037-05-31	Drug product	2025-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208264-003	9931458	2037-05-31	Drug product	2025-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208264-003	9931458	2037-05-31	Drug product	2025-05-09	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208264-003	9931458	2037-05-31	Drug product	2025-05-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208264-004	9931458	2037-05-31	Drug product	2026-02-12	`a50c72e98297…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208264-001	ODE-129	2024-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208264-002	ODE-129	2024-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208264-001	ODE-129	2024-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208264-002	ODE-129	2024-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208264-001	ODE-129	2024-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208264-002	ODE-129	2024-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208264-001	ODE-129	2024-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208264-002	ODE-129	2024-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208264-001	ODE-129	2024-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208264-002	ODE-129	2024-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208264-001	ODE-129	2024-01-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208264-002	ODE-129	2024-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208264-001	ODE-129	2024-01-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208264-002	ODE-129	2024-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208264-001	ODE-129	2024-01-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208264-002	ODE-129	2024-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208264-001	ODE-129	2024-01-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208264-002	ODE-129	2024-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208264-001	ODE-129	2024-01-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208264-002	ODE-129	2024-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208264-001	ODE-129	2024-01-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208264-002	ODE-129	2024-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208264-001	ODE-129	2024-01-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208264-002	ODE-129	2024-01-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208264-001	I-747	2020-01-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208264-001	ODE-129	2024-01-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208264-002	I-747	2020-01-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208264-002	ODE-129	2024-01-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208264-001	ODE-129	2024-01-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208264-002	ODE-129	2024-01-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208264-001	ODE-129	2024-01-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208264-002	ODE-129	2024-01-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208264-001	ODE-129	2024-01-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208264-002	ODE-129	2024-01-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208264-001	ODE-129	2024-01-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208264-002	ODE-129	2024-01-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208264-001	I-747	2020-01-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208264-001	ODE-129	2024-01-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208264-002	I-747	2020-01-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208264-002	ODE-129	2024-01-26	`8869cabd3fbd…`

Additional Listing Data#

Finished product: Yes
Brand name base: TEPADINA
Listing expiration: 2027-12-31

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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1660004	Internal RxNorm lookup
1660009	Internal RxNorm lookup
1919209	Internal RxNorm lookup
1919211	Internal RxNorm lookup
2712232	Internal RxNorm lookup
2712234	Internal RxNorm lookup
2734124	Internal RxNorm lookup
2734126	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
559e353c-2dc0-16ba-e054-00144ff8d46c	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
70121-1631-1	TEPADINA	1 in 1 VIAL, GLASS	INJECTION, POWDER, FOR SOLUTION	1		30
70121-1631-1	TEPADINA	1 in 1 BOX	INJECTION, POWDER, FOR SOLUTION	1		30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70121-1631-1	EA - Each	70121-1631	8c171a3b-fcba-4350-a7ee-3c62a2826145	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70121-1631	TEPADINA (THIOTEPA) INJECTION, POWDER, FOR SOLUTION TEPADINA (THIOTEPA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC]	23	Current NDC, Legacy NDC, 2 package rows	20250426_559e353c-2dc0-16ba-e054-00144ff8d46c.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
TEPADINA	THIOTEPA	Amneal Pharmaceuticals LLC	559e353c-2dc0-16ba-e054-00144ff8d46c	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208264 application number: NDA208264 ndc (product): 70121-1631

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
1919209	TEPADINA 100 MG Injection	PSN	559e353c-2dc0-16ba-e054-00144ff8d46c	30
1919211	TEPADINA 15 MG Injection	PSN	559e353c-2dc0-16ba-e054-00144ff8d46c	30
2712234	TEPADINA 200 MG Injection	PSN	559e353c-2dc0-16ba-e054-00144ff8d46c	30
2734126	TEPADINA 400 MG Injection	PSN	559e353c-2dc0-16ba-e054-00144ff8d46c	30
1660004	thiotepa 100 MG Injection	PSN	559e353c-2dc0-16ba-e054-00144ff8d46c	30
1660009	thiotepa 15 MG Injection	PSN	559e353c-2dc0-16ba-e054-00144ff8d46c	30
2712232	thiotepa 200 MG Injection	PSN	559e353c-2dc0-16ba-e054-00144ff8d46c	30
2734124	thiotepa 400 MG Injection	PSN	559e353c-2dc0-16ba-e054-00144ff8d46c	30
1919209	thiotepa 100 MG Injection [Tepadina]	SBD	559e353c-2dc0-16ba-e054-00144ff8d46c	30
1919211	thiotepa 15 MG Injection [Tepadina]	SBD	559e353c-2dc0-16ba-e054-00144ff8d46c	30
2712234	thiotepa 200 MG Injection [Tepadina]	SBD	559e353c-2dc0-16ba-e054-00144ff8d46c	30
2734126	thiotepa 400 MG Injection [Tepadina]	SBD	559e353c-2dc0-16ba-e054-00144ff8d46c	30
1660004	thiotepa 100 MG Injection	SCD	559e353c-2dc0-16ba-e054-00144ff8d46c	30
1660009	thiotepa 15 MG Injection	SCD	559e353c-2dc0-16ba-e054-00144ff8d46c	30
2712232	thiotepa 200 MG Injection	SCD	559e353c-2dc0-16ba-e054-00144ff8d46c	30
2734124	thiotepa 400 MG Injection	SCD	559e353c-2dc0-16ba-e054-00144ff8d46c	30
1919209	Tepadina 100 MG Injection	SY	559e353c-2dc0-16ba-e054-00144ff8d46c	30
1919211	Tepadina 15 MG Injection	SY	559e353c-2dc0-16ba-e054-00144ff8d46c	30
2712234	Tepadina 200 MG Injection	SY	559e353c-2dc0-16ba-e054-00144ff8d46c	30
2734126	Tepadina 400 MG Injection	SY	559e353c-2dc0-16ba-e054-00144ff8d46c	30
1660004	TSPA 100 MG Injection	SY	559e353c-2dc0-16ba-e054-00144ff8d46c	30
1919209	TSPA 100 MG Injection [Tepadina]	SY	559e353c-2dc0-16ba-e054-00144ff8d46c	30
1660009	TSPA 15 MG Injection	SY	559e353c-2dc0-16ba-e054-00144ff8d46c	30
1919211	TSPA 15 MG Injection [Tepadina]	SY	559e353c-2dc0-16ba-e054-00144ff8d46c	30
2712232	TSPA 200 MG Injection	SY	559e353c-2dc0-16ba-e054-00144ff8d46c	30
2712234	TSPA 200 MG Injection [Tepadina]	SY	559e353c-2dc0-16ba-e054-00144ff8d46c	30
2734124	TSPA 400 MG Injection	SY	559e353c-2dc0-16ba-e054-00144ff8d46c	30
2734126	TSPA 400 MG Injection [Tepadina]	SY	559e353c-2dc0-16ba-e054-00144ff8d46c	30

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70121-1631-1	70121163101	1 VIAL, GLASS in 1 BOX (70121-1631-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS	2017-08-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TEPADINA	Amneal Pharmaceuticals LLC \| Adienne S.r.l. \| BSP Pharmaceuticals SpA \| CIT SRL \| Eurofins Biolab Srl \| Indena SpA \| LabAnalysis Life Science srl \| NerPharMa S.r.l	2026-01-30	HUMAN PRESCRIPTION DRUG LABEL	30