Thalomid

Product NDC: 59572-205
11-digit product format: 595720205
Labeler code: 59572
Product ID: 59572-205_251b6592-f5ae-4b1b-8223-21d51f7a192d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Thalidomide
Dosage form: CAPSULE
Route: ORAL
Labeler: Celgene Corporation
Application: NDA020785
Marketing category: NDA
Marketing start: 2003-06-20
Substance: THALIDOMIDE
Active strength: 50 mg/1
Pharmacologic classes: Decreased Immunologically Active Molecule Activity [PE]
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 44.

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
N020785-001	THALOMID	THALIDOMIDE	50MG	CAPSULE / ORAL	AB	RLD	1998-07-16
N020785-002	THALOMID	THALIDOMIDE	100MG	CAPSULE / ORAL	AB	RLD	2003-01-17
N020785-003	THALOMID	THALIDOMIDE	200MG	CAPSULE / ORAL	AB	RLD, RS	2003-01-17
N020785-004	THALOMID	THALIDOMIDE	150MG	CAPSULE / ORAL		RLD	2007-01-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N020785-001	AB
N020785-002	AB
N020785-003	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.

Product history page 1 of 5 · 176 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
2026-10-15 13:18:30	2026-09	N020785-001	THALOMID	50MG	CAPSULE / ORAL	AB	RLD	1998-07-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020785-002	THALOMID	100MG	CAPSULE / ORAL	AB	RLD	2003-01-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020785-003	THALOMID	200MG	CAPSULE / ORAL	AB	RLD, RS	2003-01-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020785-004	THALOMID	150MG	CAPSULE / ORAL		RLD	2007-01-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020785-001	THALOMID	50MG	CAPSULE / ORAL	AB	RLD	1998-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020785-002	THALOMID	100MG	CAPSULE / ORAL	AB	RLD	2003-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020785-003	THALOMID	200MG	CAPSULE / ORAL	AB	RLD, RS	2003-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020785-004	THALOMID	150MG	CAPSULE / ORAL		RLD	2007-01-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020785-001	THALOMID	50MG	CAPSULE / ORAL	AB	RLD	1998-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020785-002	THALOMID	100MG	CAPSULE / ORAL	AB	RLD	2003-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020785-003	THALOMID	200MG	CAPSULE / ORAL	AB	RLD, RS	2003-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020785-004	THALOMID	150MG	CAPSULE / ORAL		RLD	2007-01-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020785-001	THALOMID	50MG	CAPSULE / ORAL		RLD	1998-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020785-002	THALOMID	100MG	CAPSULE / ORAL		RLD	2003-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020785-003	THALOMID	200MG	CAPSULE / ORAL		RLD, RS	2003-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020785-004	THALOMID	150MG	CAPSULE / ORAL		RLD	2007-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020785-001	THALOMID	50MG	CAPSULE / ORAL		RLD	1998-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020785-002	THALOMID	100MG	CAPSULE / ORAL		RLD	2003-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020785-003	THALOMID	200MG	CAPSULE / ORAL		RLD, RS	2003-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020785-004	THALOMID	150MG	CAPSULE / ORAL		RLD	2007-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020785-001	THALOMID	50MG	CAPSULE / ORAL		RLD	1998-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020785-002	THALOMID	100MG	CAPSULE / ORAL		RLD	2003-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020785-003	THALOMID	200MG	CAPSULE / ORAL		RLD, RS	2003-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020785-004	THALOMID	150MG	CAPSULE / ORAL		RLD	2007-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020785-001	THALOMID	50MG	CAPSULE / ORAL		RLD	1998-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020785-002	THALOMID	100MG	CAPSULE / ORAL		RLD	2003-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020785-003	THALOMID	200MG	CAPSULE / ORAL		RLD, RS	2003-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020785-004	THALOMID	150MG	CAPSULE / ORAL		RLD	2007-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020785-001	THALOMID	50MG	CAPSULE / ORAL		RLD	1998-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020785-002	THALOMID	100MG	CAPSULE / ORAL		RLD	2003-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020785-003	THALOMID	200MG	CAPSULE / ORAL		RLD, RS	2003-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020785-004	THALOMID	150MG	CAPSULE / ORAL		RLD	2007-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020785-001	THALOMID	50MG	CAPSULE / ORAL		RLD	1998-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020785-002	THALOMID	100MG	CAPSULE / ORAL		RLD	2003-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020785-003	THALOMID	200MG	CAPSULE / ORAL		RLD, RS	2003-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020785-004	THALOMID	150MG	CAPSULE / ORAL		RLD	2007-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020785-001	THALOMID	50MG	CAPSULE / ORAL		RLD	1998-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020785-002	THALOMID	100MG	CAPSULE / ORAL		RLD	2003-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020785-003	THALOMID	200MG	CAPSULE / ORAL		RLD, RS	2003-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020785-004	THALOMID	150MG	CAPSULE / ORAL		RLD	2007-01-10	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N020785-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020785-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020785-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020785-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020785-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020785-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020785-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020785-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020785-003	AB	1	`caaa826d4ba7…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020785-004	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020785-004	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020785-004	AB	1	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020785-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020785-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020785-003	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 426 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020785-001	7230012	2023-12-09		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020785-002	7230012	2023-12-09		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020785-003	7230012	2023-12-09		Drug product		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020785-001	7230012	2023-12-09		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020785-002	7230012	2023-12-09		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020785-003	7230012	2023-12-09		Drug product		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020785-001	7230012	2023-12-09		Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020785-002	7230012	2023-12-09		Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020785-003	7230012	2023-12-09		Drug product		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6315720	2020-10-23	U-731			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6315720	2020-10-23	U-442			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6561977	2020-10-23	U-731			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6561977	2020-10-23	U-371			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6755784	2020-10-23	U-371			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6755784	2020-10-23	U-731			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6869399	2020-10-23	U-371			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6869399	2020-10-23	U-732			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6869399	2020-10-23	U-733			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	6869399	2020-10-23	U-731			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	7141018	2020-10-23	U-733			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	7141018	2020-10-23	U-731			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	7141018	2020-10-23	U-732			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	7141018	2020-10-23	U-371			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	7959566	2020-10-23	U-1155		2011-06-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	8315886	2020-10-23	U-1249			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	8626531	2020-10-23	U-1465		2014-02-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-001	7230012	2023-12-09		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6315720	2020-10-23	U-731			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6315720	2020-10-23	U-442			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6561977	2020-10-23	U-731			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6561977	2020-10-23	U-371			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6755784	2020-10-23	U-371			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6755784	2020-10-23	U-731			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6869399	2020-10-23	U-371			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6869399	2020-10-23	U-732			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6869399	2020-10-23	U-731			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	6869399	2020-10-23	U-733			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	7141018	2020-10-23	U-732			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	7141018	2020-10-23	U-371			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020785-002	7141018	2020-10-23	U-733			`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
THALIDOMIDE	50 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
238d3357-f36e-2a45-a884-8c335f9ac704	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59572-205-14	Thalomid	28 in 1 BLISTER PACK	CAPSULE	28	25
59572-205-17	Thalomid	1 in 1 BLISTER PACK	CAPSULE	1	25
59572-205-94	Thalomid	10 in 1 BOX	CAPSULE	10	25
59572-205-97	Thalomid	10 in 1 BOX	CAPSULE	10	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59572-205-14	EA - Each	59572-205	a90ff79d-2d34-41a1-b961-dea758ff4d99	1	2012-07-24
59572-205-17	EA - Each	59572-205	4b2d02d1-2b59-48eb-b426-a96b8ced641c	1	2012-07-24
59572-205-94	EA - Each	59572-205	cf5506f1-f343-4585-abb3-d9a86d2ab816	1	2012-07-24
59572-205-97	EA - Each	59572-205	8d159534-3c4d-4d05-9a21-5f4d5b8d1b24	1	2013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
THALIDOMIDE	ACTIVE INGREDIENT	4Z8R6ORS6L	THALOMID (THALIDOMIDE) CAPSULE [CELGENE CORPORATION]	12
THALIDOMIDE	ACTIVE MOIETY	4Z8R6ORS6L	THALOMID (THALIDOMIDE) CAPSULE [CELGENE CORPORATION]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	THALOMID (THALIDOMIDE) CAPSULE [CELGENE CORPORATION]	12
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	THALOMID (THALIDOMIDE) CAPSULE [CELGENE CORPORATION]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59572-205	THALOMID (THALIDOMIDE) CAPSULE [CELGENE CORPORATION]	25	Current NDC, Legacy NDC, 4 package rows	20230406_2eda833b-1357-4ed4-a093-194524fcb061.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Z8R6ORS6L	THALIDOMIDE	50-35-1	THALIDOMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
360176	thalidomide 100 MG Oral Capsule	PSN	2eda833b-1357-4ed4-a093-194524fcb061	25
700416	thalidomide 150 MG Oral Capsule	PSN	2eda833b-1357-4ed4-a093-194524fcb061	25
360177	thalidomide 200 MG Oral Capsule	PSN	2eda833b-1357-4ed4-a093-194524fcb061	25
200390	thalidomide 50 MG Oral Capsule	PSN	2eda833b-1357-4ed4-a093-194524fcb061	25
404449	Thalomid 100 MG Oral Capsule	PSN	2eda833b-1357-4ed4-a093-194524fcb061	25
700418	Thalomid 150 MG Oral Capsule	PSN	2eda833b-1357-4ed4-a093-194524fcb061	25
404450	Thalomid 200 MG Oral Capsule	PSN	2eda833b-1357-4ed4-a093-194524fcb061	25
213360	Thalomid 50 MG Oral Capsule	PSN	2eda833b-1357-4ed4-a093-194524fcb061	25
404449	thalidomide 100 MG Oral Capsule [Thalomid]	SBD	2eda833b-1357-4ed4-a093-194524fcb061	25
700418	thalidomide 150 MG Oral Capsule [Thalomid]	SBD	2eda833b-1357-4ed4-a093-194524fcb061	25
404450	thalidomide 200 MG Oral Capsule [Thalomid]	SBD	2eda833b-1357-4ed4-a093-194524fcb061	25
213360	thalidomide 50 MG Oral Capsule [Thalomid]	SBD	2eda833b-1357-4ed4-a093-194524fcb061	25
360176	thalidomide 100 MG Oral Capsule	SCD	2eda833b-1357-4ed4-a093-194524fcb061	25
700416	thalidomide 150 MG Oral Capsule	SCD	2eda833b-1357-4ed4-a093-194524fcb061	25
360177	thalidomide 200 MG Oral Capsule	SCD	2eda833b-1357-4ed4-a093-194524fcb061	25
200390	thalidomide 50 MG Oral Capsule	SCD	2eda833b-1357-4ed4-a093-194524fcb061	25
404449	Thalomid 100 MG Oral Capsule	SY	2eda833b-1357-4ed4-a093-194524fcb061	25
700418	Thalomid 150 MG Oral Capsule	SY	2eda833b-1357-4ed4-a093-194524fcb061	25
404450	Thalomid 200 MG Oral Capsule	SY	2eda833b-1357-4ed4-a093-194524fcb061	25
213360	Thalomid 50 MG Oral Capsule	SY	2eda833b-1357-4ed4-a093-194524fcb061	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59572-205-14	59572020514	28 in 1 BLISTER PACK						Historical
59572-205-17	59572020517	1 in 1 BLISTER PACK						Historical
59572-205-94	59572020594	10 BLISTER PACK in 1 BOX (59572-205-94) / 28 CAPSULE in 1 BLISTER PACK (59572-205-14)	10 blister pack	2003-06-20	0000-00-00	No	No	Current
59572-205-97	59572020597	10 BLISTER PACK in 1 BOX (59572-205-97) / 1 CAPSULE in 1 BLISTER PACK (59572-205-17)	10 blister pack	2011-01-26	0000-00-00	No	No	Current