silodosin

Generic: silodosin

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

Drug Facts

Product Profile

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

silodosin 8 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-385
Product ID 33342-385_4a96f732-bbce-426f-9780-89115cac638b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211166
Listing Expiration 2026-12-31
Marketing Start 2018-12-03

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 33342385
Hyphenated Format 33342-385

Supplemental Identifiers

RxCUI
809477 826612
UPC
0333342385109 0333342385079 0333342384102 0333342384072
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 ANDA211166 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (33342-385-07)
  • 90 CAPSULE in 1 BOTTLE (33342-385-10)
  • 100 BLISTER PACK in 1 CARTON (33342-385-12) / 10 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (3)

33342-385-07 30 CAPSULE in 1 BOTTLE (33342-385-07) 33342-385-10 90 CAPSULE in 1 BOTTLE (33342-385-10) 33342-385-12 100 BLISTER PACK in 1 CARTON (33342-385-12) / 10 CAPSULE in 1 BLISTER PACK

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": "4a96f732-bbce-426f-9780-89115cac638b", "openfda": {"nui": ["N0000000099", "N0000175553"], "upc": ["0333342385109", "0333342385079", "0333342384102", "0333342384072"], "unii": ["CUZ39LUY82"], "rxcui": ["809477", "826612"], "spl_set_id": ["58af9a98-b1a1-4f30-b535-6647f1effed4"], "pharm_class_epc": ["alpha-Adrenergic Blocker [EPC]"], "pharm_class_moa": ["Adrenergic alpha-Antagonists [MoA]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (33342-385-07)", "package_ndc": "33342-385-07", "marketing_start_date": "20181203"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (33342-385-10)", "package_ndc": "33342-385-10", "marketing_start_date": "20181203"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (33342-385-12)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "33342-385-12", "marketing_start_date": "20181203"}], "brand_name": "Silodosin", "product_id": "33342-385_4a96f732-bbce-426f-9780-89115cac638b", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "33342-385", "generic_name": "Silodosin", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Silodosin", "active_ingredients": [{"name": "SILODOSIN", "strength": "8 mg/1"}], "application_number": "ANDA211166", "marketing_category": "ANDA", "marketing_start_date": "20181203", "listing_expiration_date": "20261231"}