silodosin

Generic: silodosin

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

Drug Facts

Product Profile

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

silodosin 8 mg/1

Manufacturer
Creekwood Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 82619-114
Product ID 82619-114_40b94d7e-71fd-6dce-e063-6394a90a2e10
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213230
Listing Expiration 2026-12-31
Marketing Start 2024-11-14

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 82619114
Hyphenated Format 82619-114

Supplemental Identifiers

RxCUI
809477 826612
UPC
0382619114010 0382619114027 0382619113013
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 ANDA213230 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (82619-114-01)
  • 90 CAPSULE in 1 BOTTLE (82619-114-02)
source: ndc

Packages (2)

82619-114-01 30 CAPSULE in 1 BOTTLE (82619-114-01) 82619-114-02 90 CAPSULE in 1 BOTTLE (82619-114-02)

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": "40b94d7e-71fd-6dce-e063-6394a90a2e10", "openfda": {"nui": ["N0000000099", "N0000175553"], "upc": ["0382619114010", "0382619114027", "0382619113013"], "unii": ["CUZ39LUY82"], "rxcui": ["809477", "826612"], "spl_set_id": ["43f83422-680f-411e-bbc3-2b092e64a017"], "pharm_class_epc": ["alpha-Adrenergic Blocker [EPC]"], "pharm_class_moa": ["Adrenergic alpha-Antagonists [MoA]"], "manufacturer_name": ["Creekwood Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (82619-114-01)", "package_ndc": "82619-114-01", "marketing_start_date": "20241114"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (82619-114-02)", "package_ndc": "82619-114-02", "marketing_start_date": "20241114"}], "brand_name": "SILODOSIN", "product_id": "82619-114_40b94d7e-71fd-6dce-e063-6394a90a2e10", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "82619-114", "generic_name": "silodosin", "labeler_name": "Creekwood Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SILODOSIN", "active_ingredients": [{"name": "SILODOSIN", "strength": "8 mg/1"}], "application_number": "ANDA213230", "marketing_category": "ANDA", "marketing_start_date": "20241114", "listing_expiration_date": "20261231"}