Pomalidomide

Product NDC: 63850-0131
11-digit product format: 638500131
Labeler code: 63850
Product ID: 63850-0131_0169dbda-53df-4cd9-b989-ff7544f1bdf5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pomalidomide
Dosage form: CAPSULE
Route: ORAL
Labeler: Natco Pharma Limited
Application: ANDA210111
Marketing category: ANDA
Marketing start: 2025-11-01
Substance: POMALIDOMIDE
Active strength: 1 mg/1
Pharmacologic classes: Thalidomide Analog [EPC]
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	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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POMALIDOMIDE	1 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
0169dbda-53df-4cd9-b989-ff7544f1bdf5	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63850-0131-1	Pomalidomide	21 in 1 BOTTLE	CAPSULE	21		1
63850-0131-2	Pomalidomide	100 in 1 BOTTLE	CAPSULE	100		1

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
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 ndc (product): 63850-0131

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	0169dbda-53df-4cd9-b989-ff7544f1bdf5	1
1369726	pomalidomide 2 MG Oral Capsule	PSN	0169dbda-53df-4cd9-b989-ff7544f1bdf5	1
1369730	pomalidomide 3 MG Oral Capsule	PSN	0169dbda-53df-4cd9-b989-ff7544f1bdf5	1
1369734	pomalidomide 4 MG Oral Capsule	PSN	0169dbda-53df-4cd9-b989-ff7544f1bdf5	1
1369718	pomalidomide 1 MG Oral Capsule	SCD	0169dbda-53df-4cd9-b989-ff7544f1bdf5	1
1369726	pomalidomide 2 MG Oral Capsule	SCD	0169dbda-53df-4cd9-b989-ff7544f1bdf5	1
1369730	pomalidomide 3 MG Oral Capsule	SCD	0169dbda-53df-4cd9-b989-ff7544f1bdf5	1
1369734	pomalidomide 4 MG Oral Capsule	SCD	0169dbda-53df-4cd9-b989-ff7544f1bdf5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63850-0131-1	63850013101	21 CAPSULE in 1 BOTTLE (63850-0131-1)	21 capsule	2025-11-01	No	No	Current
63850-0131-2	63850013102	100 CAPSULE in 1 BOTTLE (63850-0131-2)	100 capsule	2025-11-01	No	No	Current