Silodosin

Product NDC
62332-406
11-digit product format
623320406
Labeler code
62332
Product ID
62332-406_afb792df-ffe3-4c77-a9dc-5eb831b2401b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silodosin
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA211731
Marketing category
ANDA
Marketing start
2019-11-25
Substance
SILODOSIN
Active strength
8 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211731-001SILODOSINSILODOSIN4MGCAPSULE / ORAL2019-11-22
A211731-002SILODOSINSILODOSIN8MGCAPSULE / ORAL2019-11-22

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-22caaa826d4ba7…
2026-08-18 06:07:402026-07A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-224b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211731-001SILODOSIN4MGCAPSULE / ORAL2019-11-22782e0a99824c…
2021-12-28 21:50 UTC2021-12A211731-002SILODOSIN8MGCAPSULE / ORAL2019-11-22782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2020-12-22 03:56 UTC2020-12A211731-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A211731-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211731-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A211731-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211731-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A211731-002AB13f01610625f2…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILODOSIN8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CUZ39LUY82Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
809477Internal RxNorm lookup
826612Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9a4d0d64-39bc-4d16-b040-8554eff19ee3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
089fe5d1-1a90-7a8e-a24a-107c84472400Product name420200507

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-406-30Silodosin30 in 1 BOTTLECAPSULE305
62332-406-90Silodosin90 in 1 BOTTLECAPSULE905
62332-406-91Silodosin1000 in 1 BOTTLECAPSULE10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-406SILODOSIN CAPSULE [ALEMBIC PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 3 package rows20210716_9a4d0d64-39bc-4d16-b040-8554eff19ee3.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SilodosinSILODOSINAlembic Pharmaceuticals Limited322ce16e-485f-4fd2-bb30-6b4776bc9e852023-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211731
application number: ANDA211731
SilodosinSILODOSINAlembic Pharmaceuticals Inc.9a4d0d64-39bc-4d16-b040-8554eff19ee32021-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211731
application number: ANDA211731
ndc (product): 62332-406

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
826612silodosin 4 MG Oral CapsulePSN9a4d0d64-39bc-4d16-b040-8554eff19ee35
809477silodosin 8 MG Oral CapsulePSN9a4d0d64-39bc-4d16-b040-8554eff19ee35
826612silodosin 4 MG Oral CapsuleSCD9a4d0d64-39bc-4d16-b040-8554eff19ee35
809477silodosin 8 MG Oral CapsuleSCD9a4d0d64-39bc-4d16-b040-8554eff19ee35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-406-306233204063030 CAPSULE in 1 BOTTLE (62332-406-30) 30 capsule2019-11-250000-00-00NoNoCurrent
62332-406-906233204069090 CAPSULE in 1 BOTTLE (62332-406-90) 90 capsule2019-11-250000-00-00NoNoCurrent
62332-406-91623320406911000 CAPSULE in 1 BOTTLE (62332-406-91) 1000 capsule2019-11-250000-00-00NoNoCurrent