silodosin

Generic: silodosin

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name silodosin
Generic Name silodosin
Labeler amneal pharmaceuticals ny llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

silodosin 4 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 60219-1421
Product ID 60219-1421_39f09c3f-1ddd-44fb-a71e-18d9a9486654
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209745
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 602191421
Hyphenated Format 60219-1421

Supplemental Identifiers

RxCUI
809477 826612
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 ANDA209745 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (60219-1421-3)
  • 90 CAPSULE in 1 BOTTLE (60219-1421-9)
source: ndc

Packages (2)

60219-1421-3 30 CAPSULE in 1 BOTTLE (60219-1421-3) 60219-1421-9 90 CAPSULE in 1 BOTTLE (60219-1421-9)

Ingredients (1)

silodosin (4 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": "39f09c3f-1ddd-44fb-a71e-18d9a9486654", "openfda": {"nui": ["N0000000099", "N0000175553"], "unii": ["CUZ39LUY82"], "rxcui": ["809477", "826612"], "spl_set_id": ["455c98be-aa01-4393-915f-34d1859005c0"], "pharm_class_epc": ["alpha-Adrenergic Blocker [EPC]"], "pharm_class_moa": ["Adrenergic alpha-Antagonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (60219-1421-3)", "package_ndc": "60219-1421-3", "marketing_start_date": "20181203"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (60219-1421-9)", "package_ndc": "60219-1421-9", "marketing_start_date": "20181203"}], "brand_name": "Silodosin", "product_id": "60219-1421_39f09c3f-1ddd-44fb-a71e-18d9a9486654", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "60219-1421", "generic_name": "Silodosin", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Silodosin", "active_ingredients": [{"name": "SILODOSIN", "strength": "4 mg/1"}], "application_number": "ANDA209745", "marketing_category": "ANDA", "marketing_start_date": "20181203", "listing_expiration_date": "20261231"}