Silodosin

Product NDC: 46708-405
11-digit product format: 467080405
Labeler code: 46708
Product ID: 46708-405_74147395-217c-4a7c-8acf-92a95ca7b7d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Silodosin
Dosage form: CAPSULE
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA211731
Marketing category: ANDA
Marketing start: 2019-11-25
Substance: SILODOSIN
Active strength: 4 mg/1
Pharmacologic classes: Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211731-001	SILODOSIN	SILODOSIN	4MG	CAPSULE / ORAL			2019-11-22
A211731-002	SILODOSIN	SILODOSIN	8MG	CAPSULE / ORAL			2019-11-22

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 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211731-001	SILODOSIN	4MG	CAPSULE / ORAL	2019-11-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211731-002	SILODOSIN	8MG	CAPSULE / ORAL	2019-11-22	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A211731-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211731-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211731-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211731-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211731-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211731-002	AB	1	`3f01610625f2…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SILODOSIN	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CUZ39LUY82	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
809477	Internal RxNorm lookup
826612	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
322ce16e-485f-4fd2-bb30-6b4776bc9e85	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
089fe5d1-1a90-7a8e-a24a-107c84472400	Product name	4	20200507

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
46708-405-30	2023-02-01	These highlights do not include all the information needed to use SILODOSIN CAPSULES safely and effectively. See full prescribing information for SILODOSIN CAPSULES. SILODOSIN capsules, for oral use Initial U.S. Approval: 2008
46708-405-90	2023-02-01	These highlights do not include all the information needed to use SILODOSIN CAPSULES safely and effectively. See full prescribing information for SILODOSIN CAPSULES. SILODOSIN capsules, for oral use Initial U.S. Approval: 2008
46708-405-91	2023-02-01	These highlights do not include all the information needed to use SILODOSIN CAPSULES safely and effectively. See full prescribing information for SILODOSIN CAPSULES. SILODOSIN capsules, for oral use Initial U.S. Approval: 2008
46708-405-30	2023-01-30	These highlights do not include all the information needed to use SILODOSIN CAPSULES safely and effectively. See full prescribing information for SILODOSIN CAPSULES. SILODOSIN capsules, for oral use Initial U.S. Approval: 2008
46708-405-90	2023-01-30	These highlights do not include all the information needed to use SILODOSIN CAPSULES safely and effectively. See full prescribing information for SILODOSIN CAPSULES. SILODOSIN capsules, for oral use Initial U.S. Approval: 2008
46708-405-91	2023-01-30	These highlights do not include all the information needed to use SILODOSIN CAPSULES safely and effectively. See full prescribing information for SILODOSIN CAPSULES. SILODOSIN capsules, for oral use Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46708-405-30	Silodosin	30 in 1 BOTTLE	CAPSULE	30	2
46708-405-90	Silodosin	90 in 1 BOTTLE	CAPSULE	90	2
46708-405-91	Silodosin	1000 in 1 BOTTLE	CAPSULE	1000	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-405	SILODOSIN CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED]	2	Current NDC, Legacy NDC, 3 package rows	20230202_322ce16e-485f-4fd2-bb30-6b4776bc9e85.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Silodosin	SILODOSIN	Alembic Pharmaceuticals Limited	322ce16e-485f-4fd2-bb30-6b4776bc9e85	2023-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211731 application number: ANDA211731 ndc (product): 46708-405
Silodosin	SILODOSIN	Alembic Pharmaceuticals Inc.	9a4d0d64-39bc-4d16-b040-8554eff19ee3	2021-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211731 application number: ANDA211731

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CUZ39LUY82	SILODOSIN	160970-54-7	SILODOSIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
826612	silodosin 4 MG Oral Capsule	PSN	322ce16e-485f-4fd2-bb30-6b4776bc9e85	2
809477	silodosin 8 MG Oral Capsule	PSN	322ce16e-485f-4fd2-bb30-6b4776bc9e85	2
826612	silodosin 4 MG Oral Capsule	SCD	322ce16e-485f-4fd2-bb30-6b4776bc9e85	2
809477	silodosin 8 MG Oral Capsule	SCD	322ce16e-485f-4fd2-bb30-6b4776bc9e85	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-405-30	46708040530	30 CAPSULE in 1 BOTTLE (46708-405-30)	30 capsule	2019-11-25	0000-00-00	No	No	Current
46708-405-90	46708040590	90 CAPSULE in 1 BOTTLE (46708-405-90)	90 capsule	2019-11-25	0000-00-00	No	No	Current
46708-405-91	46708040591	1000 CAPSULE in 1 BOTTLE (46708-405-91)	1000 capsule	2019-11-25	0000-00-00	No	No	Current