silodosin

Generic: silodosin

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name silodosin
Generic Name silodosin
Labeler avkare
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

silodosin 4 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-777
Product ID 42291-777_4875ae6d-fc8a-e013-e063-6394a90a97f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209745
Listing Expiration 2027-12-31
Marketing Start 2022-10-04

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 42291777
Hyphenated Format 42291-777

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 (42291-777-30)
source: ndc

Packages (1)

42291-777-30 30 CAPSULE in 1 BOTTLE (42291-777-30)

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": "4875ae6d-fc8a-e013-e063-6394a90a97f2", "openfda": {"nui": ["N0000000099", "N0000175553"], "unii": ["CUZ39LUY82"], "rxcui": ["809477", "826612"], "spl_set_id": ["ea3bbafb-d32a-d0d3-e053-2a95a90ac387"], "pharm_class_epc": ["alpha-Adrenergic Blocker [EPC]"], "pharm_class_moa": ["Adrenergic alpha-Antagonists [MoA]"], "manufacturer_name": ["AvKARE"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (42291-777-30)", "package_ndc": "42291-777-30", "marketing_start_date": "20221004"}], "brand_name": "Silodosin", "product_id": "42291-777_4875ae6d-fc8a-e013-e063-6394a90a97f2", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "42291-777", "generic_name": "Silodosin", "labeler_name": "AvKARE", "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": "20221004", "listing_expiration_date": "20271231"}