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 4 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-351
Product ID 72789-351_40bb71ff-387e-bd53-e063-6394a90a38ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210626
Listing Expiration 2026-12-31
Marketing Start 2018-12-10

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 72789351
Hyphenated Format 72789-351

Supplemental Identifiers

RxCUI
826612
UPC
0372789351308
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 ANDA210626 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-351-30)
source: ndc

Packages (1)

Ingredients (1)

silodosin (4 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "40bb71ff-387e-bd53-e063-6394a90a38ef", "openfda": {"nui": ["N0000000099", "N0000175553"], "upc": ["0372789351308"], "unii": ["CUZ39LUY82"], "rxcui": ["826612"], "spl_set_id": ["94bca72c-c74a-4181-8b6a-a0a2f654a0a7"], "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 (72789-351-30)", "package_ndc": "72789-351-30", "marketing_start_date": "20230922"}], "brand_name": "SILODOSIN", "product_id": "72789-351_40bb71ff-387e-bd53-e063-6394a90a38ef", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "72789-351", "generic_name": "SILODOSIN", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SILODOSIN", "active_ingredients": [{"name": "SILODOSIN", "strength": "4 mg/1"}], "application_number": "ANDA210626", "marketing_category": "ANDA", "marketing_start_date": "20181210", "listing_expiration_date": "20261231"}