silodosin

Generic: silodosin

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name silodosin
Generic Name silodosin
Labeler lupin pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

silodosin 8 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-741
Product ID 68180-741_9a808ee1-339e-42a3-b55c-b655c9d1fcb8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206541
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 68180741
Hyphenated Format 68180-741

Supplemental Identifiers

RxCUI
809477 826612
UPC
0368180741091 0368180740063
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 ANDA206541 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (68180-741-06)
  • 90 CAPSULE in 1 BOTTLE (68180-741-09)
source: ndc

Packages (2)

68180-741-06 30 CAPSULE in 1 BOTTLE (68180-741-06) 68180-741-09 90 CAPSULE in 1 BOTTLE (68180-741-09)

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": "9a808ee1-339e-42a3-b55c-b655c9d1fcb8", "openfda": {"nui": ["N0000000099", "N0000175553"], "upc": ["0368180741091", "0368180740063"], "unii": ["CUZ39LUY82"], "rxcui": ["809477", "826612"], "spl_set_id": ["2300db48-477f-4357-8de9-f723737071b4"], "pharm_class_epc": ["alpha-Adrenergic Blocker [EPC]"], "pharm_class_moa": ["Adrenergic alpha-Antagonists [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68180-741-06)", "package_ndc": "68180-741-06", "marketing_start_date": "20181203"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (68180-741-09)", "package_ndc": "68180-741-09", "marketing_start_date": "20181203"}], "brand_name": "Silodosin", "product_id": "68180-741_9a808ee1-339e-42a3-b55c-b655c9d1fcb8", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "68180-741", "generic_name": "Silodosin", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Silodosin", "active_ingredients": [{"name": "SILODOSIN", "strength": "8 mg/1"}], "application_number": "ANDA206541", "marketing_category": "ANDA", "marketing_start_date": "20181203", "listing_expiration_date": "20261231"}