SILODOSIN

Product NDC: 69539-052
11-digit product format: 695390052
Labeler code: 69539
Product ID: 69539-052_d7005459-601a-4bf9-9278-3cb2b06566b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SILODOSIN
Dosage form: CAPSULE
Route: ORAL
Labeler: MSN LABORATORIES PRIVATE LIMITED
Application: ANDA210687
Marketing category: ANDA
Marketing start: 2018-12-03
Marketing end: 0000-00-00
Substance: SILODOSIN
Active strength: 4 mg/1
Pharmacologic classes: Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69539-052		D	Discontinued by firm	2026-10-21
excluded package	package	69539-052	69539-052-30	D	Discontinued by firm	2026-10-21
excluded package	package	69539-052	69539-052-90	D	Discontinued by firm	2026-10-21
excluded package	package	69539-052	69539-052-99	D	Discontinued by firm	2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	69539-052-90
excluded package	package	69539-052-30
excluded package	package	69539-052-99

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A210687-001	SILODOSIN	SILODOSIN	4MG	CAPSULE / ORAL	AB		2018-12-03
A210687-002	SILODOSIN	SILODOSIN	8MG	CAPSULE / ORAL	AB		2018-12-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210687-001	AB
A210687-002	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 3 · 88 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
2026-10-15 13:18:30	2026-09	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210687-001	SILODOSIN	4MG	CAPSULE / ORAL	AB	2018-12-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210687-002	SILODOSIN	8MG	CAPSULE / ORAL	AB	2018-12-03	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A210687-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210687-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210687-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210687-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210687-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210687-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210687-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210687-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210687-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210687-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210687-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210687-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210687-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210687-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210687-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A210687-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210687-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A210687-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210687-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A210687-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210687-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210687-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210687-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210687-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210687-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210687-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210687-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210687-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210687-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210687-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210687-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210687-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210687-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210687-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210687-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A210687-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210687-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A210687-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210687-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210687-002	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69539-052	SILODOSIN CAPSULE [MSN LABORATORIES PRIVATE LIMITED]	4	Legacy NDC	20210113_36a961f1-d0a6-437b-a9ea-54735e4cd1e1.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
SILODOSIN	SILODOSIN	Novadoz Pharmaceuticals LLC	ee8d577e-948d-4164-9671-c876544ac83b	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210687 application number: ANDA210687

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69539-052-30	69539005230	30 CAPSULE in 1 BOTTLE (69539-052-30)	30 capsule	2018-12-03	0000-00-00	No	No	Current
69539-052-90	69539005290	90 CAPSULE in 1 BOTTLE (69539-052-90)	90 capsule	2018-12-03	0000-00-00	No	No	Current
69539-052-99	69539005299	1000 CAPSULE in 1 BOTTLE (69539-052-99)	1000 capsule	2018-12-03	0000-00-00	No	No	Current