Pomalidomide

Product NDC: 51991-346
11-digit product format: 519910346
Labeler code: 51991
Product ID: 51991-346_44621941-eb2e-421f-bcf0-ed39d4de70f4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pomalidomide
Dosage form: CAPSULE
Route: ORAL
Labeler: Breckenridge Pharmaceutical, Inc.
Application: ANDA210111
Marketing category: ANDA
Marketing start: 2026-02-28
Substance: POMALIDOMIDE
Active strength: 4 mg/1
Pharmacologic classes: Thalidomide Analog [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51991-346	51991-346-01	D	Discontinued by firm		2026-08-03

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	Approval date
A210111-001	POMALIDOMIDE	POMALIDOMIDE	1MG	CAPSULE / ORAL	AB	2020-10-30
A210111-002	POMALIDOMIDE	POMALIDOMIDE	2MG	CAPSULE / ORAL	AB	2020-10-30
A210111-003	POMALIDOMIDE	POMALIDOMIDE	3MG	CAPSULE / ORAL	AB	2020-10-30
A210111-004	POMALIDOMIDE	POMALIDOMIDE	4MG	CAPSULE / ORAL	AB	2020-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A210111-001	AB
A210111-002	AB
A210111-003	AB
A210111-004	AB

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
A210111-001	PC	2026-08-29
A210111-002	PC	2026-08-29
A210111-003	PC	2026-08-29
A210111-004	PC	2026-08-29

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 4 · 144 observed 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	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL	AB	2020-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL	AB	2020-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL	AB	2020-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL	AB	2020-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL		2020-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL		2020-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL		2020-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL		2020-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL		2020-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL		2020-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL		2020-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL		2020-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL		2020-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL		2020-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL		2020-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL		2020-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL		2020-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL		2020-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL		2020-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL		2020-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL		2020-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL		2020-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL		2020-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL		2020-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL		2020-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL		2020-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL		2020-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL		2020-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL		2020-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL		2020-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL		2020-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL		2020-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL		2020-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL		2020-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL		2020-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL		2020-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210111-001	POMALIDOMIDE	1MG	CAPSULE / ORAL		2020-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210111-002	POMALIDOMIDE	2MG	CAPSULE / ORAL		2020-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210111-003	POMALIDOMIDE	3MG	CAPSULE / ORAL		2020-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210111-004	POMALIDOMIDE	4MG	CAPSULE / ORAL		2020-10-30	`d06236e962d9…`

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	A210111-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210111-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210111-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210111-004	AB	1	`011fe1cb6892…`
2021-03-12 10:30 UTC	2021-03	A210111-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210111-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210111-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210111-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210111-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210111-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210111-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210111-004	AB	1	`8869cabd3fbd…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210111-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210111-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210111-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210111-004	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210111-001	PC	2026-08-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210111-002	PC	2026-08-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210111-003	PC	2026-08-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210111-004	PC	2026-08-29	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POMALIDOMIDE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
D2UX06XLB5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1369718	Internal RxNorm lookup
1369726	Internal RxNorm lookup
1369730	Internal RxNorm lookup
1369734	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
41400b90-b64e-447b-90f3-1cad58050eba	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
191ddea2-3e27-5c8d-dccc-59ef9a0abcf7	Product name	2	20250401
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51991-346-01	Pomalidomide	100 in 1 BOTTLE	CAPSULE	100		10
51991-346-21	Pomalidomide	21 in 1 BOTTLE, PLASTIC	CAPSULE	21		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51991-346-21	EA - Each	51991-346	605e7fc8-dda7-48ed-8d04-f2d4484a6364	1	2026-03-17

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pomalidomide	POMALIDOMIDE	Breckenridge Pharmaceutical, Inc.	41400b90-b64e-447b-90f3-1cad58050eba	2026-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210111 application number: ANDA210111 ndc (product): 51991-346
Pomalidomide	POMALIDOMIDE	Natco Pharma Limited	0169dbda-53df-4cd9-b989-ff7544f1bdf5	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210111 application number: ANDA210111

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D2UX06XLB5	POMALIDOMIDE	19171-19-8	POMALIDOMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1369718	pomalidomide 1 MG Oral Capsule	PSN	41400b90-b64e-447b-90f3-1cad58050eba	10
1369726	pomalidomide 2 MG Oral Capsule	PSN	41400b90-b64e-447b-90f3-1cad58050eba	10
1369730	pomalidomide 3 MG Oral Capsule	PSN	41400b90-b64e-447b-90f3-1cad58050eba	10
1369734	pomalidomide 4 MG Oral Capsule	PSN	41400b90-b64e-447b-90f3-1cad58050eba	10
1369718	pomalidomide 1 MG Oral Capsule	SCD	41400b90-b64e-447b-90f3-1cad58050eba	10
1369726	pomalidomide 2 MG Oral Capsule	SCD	41400b90-b64e-447b-90f3-1cad58050eba	10
1369730	pomalidomide 3 MG Oral Capsule	SCD	41400b90-b64e-447b-90f3-1cad58050eba	10
1369734	pomalidomide 4 MG Oral Capsule	SCD	41400b90-b64e-447b-90f3-1cad58050eba	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51991-346-01	51991034601	100 in 1 BOTTLE					Historical
51991-346-21	51991034621	21 CAPSULE in 1 BOTTLE, PLASTIC (51991-346-21)	21 capsule	2026-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pomalidomide	Breckenridge Pharmaceutical, Inc. \| Natco Pharma Ltd.	2026-03-04	HUMAN PRESCRIPTION DRUG LABEL	10