Home NDC 33342-384 Silodosin
Product NDC 33342-384
11-digit product format 333420384
Labeler code 33342
Product ID 33342-384_4a96f732-bbce-426f-9780-89115cac638b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Silodosin
Dosage form CAPSULE
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA211166
Marketing category ANDA
Marketing start 2018-12-03
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 A211166-001 SILODOSIN SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 A211166-002 SILODOSIN SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211166-001 SILODOSIN 4MG CAPSULE / ORAL AB 2018-12-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211166-002 SILODOSIN 8MG CAPSULE / ORAL AB 2018-12-03 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33342-384-07 Silodosin 30 in 1 BOTTLE CAPSULE 30 3 33342-384-10 Silodosin 90 in 1 BOTTLE CAPSULE 90 3 33342-384-12 Silodosin 10 in 1 BLISTER PACK CAPSULE 10 3 33342-384-12 Silodosin 100 in 1 CARTON CAPSULE 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-384 SILODOSIN CAPSULE [MACLEODS PHARMACEUTICALS LIMITED] 3 Current NDC, Legacy NDC, 4 package rows 20220702_58af9a98-b1a1-4f30-b535-6647f1effed4.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 33342-384-07 33342038407 30 CAPSULE in 1 BOTTLE (33342-384-07) 30 capsule 2018-12-03 0000-00-00 No No Current 33342-384-10 33342038410 90 CAPSULE in 1 BOTTLE (33342-384-10) 90 capsule 2018-12-03 0000-00-00 No No Current 33342-384-12 33342038412 100 BLISTER PACK in 1 CARTON (33342-384-12) / 10 CAPSULE in 1 BLISTER PACK 100 blister pack 2018-12-03 0000-00-00 No No Current