Sorafenib Tosylate

Product NDC: 0378-1201
11-digit product format: 003781201
Labeler code: 0378
Product ID: 0378-1201_40e1cce8-b7c1-4fad-8600-7d7b409bde7e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sorafenib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA207012
Marketing category: ANDA
Marketing start: 2022-06-01
Substance: SORAFENIB TOSYLATE
Active strength: 200 mg/1
Pharmacologic classes: Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
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 1.

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
A207012-001	SORAFENIB TOSYLATE	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB		2020-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207012-001	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL		2020-09-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL		2020-09-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL		2020-09-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL		2020-09-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL		2020-09-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL		2020-09-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL		2020-09-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL		2020-09-10	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207012-001	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	AB	2020-09-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207012-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207012-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207012-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207012-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207012-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207012-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207012-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207012-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207012-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207012-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207012-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207012-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207012-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207012-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207012-001	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207012-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207012-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207012-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207012-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207012-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207012-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207012-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207012-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207012-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207012-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207012-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207012-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207012-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207012-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SORAFENIB TOSYLATE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5T62Q3B36J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
597747	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
b7919013-1511-44f0-a759-3fa78a9fa178	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
33680929-c1c0-4a67-aa2e-1f98b8efd580	Product name	1	20240501

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-1201-78	Sorafenib Tosylate	120 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	120		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-1201-78	EA - Each	0378-1201	63df39f3-debb-4191-aa22-c5d862de29d9	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-1201	SORAFENIB TOSYLATE (SORAFENIB) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5	Current NDC, Legacy NDC, 1 package rows	20241101_b7919013-1511-44f0-a759-3fa78a9fa178.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
Sorafenib Tosylate	SORAFENIB	Mylan Pharmaceuticals Inc.	b7919013-1511-44f0-a759-3fa78a9fa178	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207012 application number: ANDA207012 ndc (product): 0378-1201

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5T62Q3B36J	SORAFENIB TOSYLATE	475207-59-1	SORAFENIB TOSYLATE
9ZOQ3TZI87	SORAFENIB	284461-73-0	Sorafenib

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
597747	SORAfenib 200 MG Oral Tablet	PSN	b7919013-1511-44f0-a759-3fa78a9fa178	6
597747	sorafenib 200 MG Oral Tablet	SCD	b7919013-1511-44f0-a759-3fa78a9fa178	6
597747	sorafenib (as sorafenib tosylate) 200 MG Oral Tablet	SY	b7919013-1511-44f0-a759-3fa78a9fa178	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-1201-78	00378120178	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1201-78)	2022-06-01	0000-00-00	No	No	Current