Thalomid

Product NDC: 59572-210
11-digit product format: 595720210
Labeler code: 59572
Product ID: 59572-210_58b287d1-24f5-4dfe-84ca-898a8a5b9302
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: 100 mg/1
Pharmacologic classes: Decreased Immunologically Active Molecule Activity [PE]
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 1.

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020785-001	THALOMID	50MG	CAPSULE / ORAL	RLD	1998-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020785-002	THALOMID	100MG	CAPSULE / ORAL	RLD	2003-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020785-003	THALOMID	200MG	CAPSULE / ORAL	RLD, RS	2003-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020785-004	THALOMID	150MG	CAPSULE / ORAL	RLD	2007-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020785-001	THALOMID	50MG	CAPSULE / ORAL	RLD	1998-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020785-002	THALOMID	100MG	CAPSULE / ORAL	RLD	2003-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020785-003	THALOMID	200MG	CAPSULE / ORAL	RLD, RS	2003-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020785-004	THALOMID	150MG	CAPSULE / ORAL	RLD	2007-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020785-001	THALOMID	50MG	CAPSULE / ORAL	RLD	1998-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020785-002	THALOMID	100MG	CAPSULE / ORAL	RLD	2003-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020785-003	THALOMID	200MG	CAPSULE / ORAL	RLD, RS	2003-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020785-004	THALOMID	150MG	CAPSULE / ORAL	RLD	2007-01-10	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
THALIDOMIDE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Z8R6ORS6L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200390	Internal RxNorm lookup
213360	Internal RxNorm lookup
360176	Internal RxNorm lookup
360177	Internal RxNorm lookup
404449	Internal RxNorm lookup
404450	Internal RxNorm lookup
700416	Internal RxNorm lookup
700418	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
2eda833b-1357-4ed4-a093-194524fcb061	Available on FDA.report

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	Strength	SPL version
59572-210-15	Thalomid	28 in 1 BLISTER PACK	CAPSULE	28		25
59572-210-95	Thalomid	5 in 1 BOX	CAPSULE	5		25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59572-210-15	EA - Each	59572-210	fd9b990e-47ec-464d-af98-02d0a7fbcc3d	1	2012-07-24
59572-210-95	EA - Each	59572-210	f1a1c5b7-c449-43a8-a25d-fd0f0ba1036f	1	2012-07-24

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
59572-210	THALOMID (THALIDOMIDE) CAPSULE [CELGENE CORPORATION]	25	Current NDC, Legacy NDC, 2 package rows	20230406_2eda833b-1357-4ed4-a093-194524fcb061.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
Thalomid	THALIDOMIDE	Celgene Corporation	2eda833b-1357-4ed4-a093-194524fcb061	2023-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020785 application number: NDA020785 ndc (product): 59572-210

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
59572-210-15	59572021015	28 in 1 BLISTER PACK						Historical
59572-210-95	59572021095	5 BLISTER PACK in 1 BOX (59572-210-95) / 28 CAPSULE in 1 BLISTER PACK (59572-210-15)	5 blister pack	2003-06-20	0000-00-00	No	No	Current