silodosin

Generic: silodosin

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name silodosin
Generic Name silodosin
Labeler alembic pharmaceuticals limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

silodosin 8 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-406
Product ID 46708-406_74147395-217c-4a7c-8acf-92a95ca7b7d4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211731
Listing Expiration 2026-12-31
Marketing Start 2019-11-25

Pharmacologic Class

Established (EPC)
alpha-adrenergic blocker [epc]
Mechanism of Action
adrenergic alpha-antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708406
Hyphenated Format 46708-406

Supplemental Identifiers

RxCUI
809477 826612
UPC
0346708406301
UNII
CUZ39LUY82
NUI
N0000000099 N0000175553

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name silodosin (source: ndc)
Generic Name silodosin (source: ndc)
Application Number ANDA211731 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (46708-406-30)
  • 90 CAPSULE in 1 BOTTLE (46708-406-90)
  • 1000 CAPSULE in 1 BOTTLE (46708-406-91)
source: ndc

Packages (3)

46708-406-30 30 CAPSULE in 1 BOTTLE (46708-406-30) 46708-406-90 90 CAPSULE in 1 BOTTLE (46708-406-90) 46708-406-91 1000 CAPSULE in 1 BOTTLE (46708-406-91)

Ingredients (1)

silodosin (8 mg/1)

Linked Drug Pages (1)

Silodosin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "74147395-217c-4a7c-8acf-92a95ca7b7d4", "openfda": {"nui": ["N0000000099", "N0000175553"], "upc": ["0346708406301"], "unii": ["CUZ39LUY82"], "rxcui": ["809477", "826612"], "spl_set_id": ["322ce16e-485f-4fd2-bb30-6b4776bc9e85"], "pharm_class_epc": ["alpha-Adrenergic Blocker [EPC]"], "pharm_class_moa": ["Adrenergic alpha-Antagonists [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (46708-406-30)", "package_ndc": "46708-406-30", "marketing_start_date": "20191125"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (46708-406-90)", "package_ndc": "46708-406-90", "marketing_start_date": "20191125"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (46708-406-91)", "package_ndc": "46708-406-91", "marketing_start_date": "20191125"}], "brand_name": "Silodosin", "product_id": "46708-406_74147395-217c-4a7c-8acf-92a95ca7b7d4", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "46708-406", "generic_name": "Silodosin", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Silodosin", "active_ingredients": [{"name": "SILODOSIN", "strength": "8 mg/1"}], "application_number": "ANDA211731", "marketing_category": "ANDA", "marketing_start_date": "20191125", "listing_expiration_date": "20261231"}