silodosin

Generic: silodosin

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

silodosin 8 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-090
Product ID 72789-090_4031d0db-272c-8e81-e063-6394a90a3b93
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210687
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 72789090
Hyphenated Format 72789-090

Supplemental Identifiers

RxCUI
809477
UPC
0372789090306
UNII
CUZ39LUY82
NUI
N0000000099 N0000175553

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 ANDA210687 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-090-30)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (72789-090-90)
source: ndc

Packages (2)

Ingredients (1)

silodosin (8 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "4031d0db-272c-8e81-e063-6394a90a3b93", "openfda": {"nui": ["N0000000099", "N0000175553"], "upc": ["0372789090306"], "unii": ["CUZ39LUY82"], "rxcui": ["809477"], "spl_set_id": ["365a86b3-748a-465d-b489-dba1479be670"], "pharm_class_epc": ["alpha-Adrenergic Blocker [EPC]"], "pharm_class_moa": ["Adrenergic alpha-Antagonists [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (72789-090-30)", "package_ndc": "72789-090-30", "marketing_start_date": "20200623"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (72789-090-90)", "package_ndc": "72789-090-90", "marketing_start_date": "20200623"}], "brand_name": "SILODOSIN", "product_id": "72789-090_4031d0db-272c-8e81-e063-6394a90a3b93", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "72789-090", "generic_name": "SILODOSIN", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SILODOSIN", "active_ingredients": [{"name": "SILODOSIN", "strength": "8 mg/1"}], "application_number": "ANDA210687", "marketing_category": "ANDA", "marketing_start_date": "20181203", "listing_expiration_date": "20261231"}