tamsulosin hydrochloride

Generic: tamsulosin hydrochloride

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

Drug Facts

Product Profile

Brand Name tamsulosin hydrochloride
Generic Name tamsulosin hydrochloride
Labeler quallent pharmaceuticals health llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tamsulosin hydrochloride .4 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-025
Product ID 82009-025_82b44507-051f-4892-a0b7-ed3955c2f72f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078225
Listing Expiration 2026-12-31
Marketing Start 2022-08-20

Pharmacologic Class

Classes
adrenergic alpha-antagonists [moa] alpha-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82009025
Hyphenated Format 82009-025

Supplemental Identifiers

RxCUI
863669
UPC
0382009025100
UNII
11SV1951MR

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 tamsulosin hydrochloride (source: ndc)
Generic Name tamsulosin hydrochloride (source: ndc)
Application Number ANDA078225 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .4 mg/1
source: ndc
Packaging
  • 1000 CAPSULE in 1 BOTTLE (82009-025-10)
source: ndc

Packages (1)

82009-025-10 1000 CAPSULE in 1 BOTTLE (82009-025-10)

Ingredients (1)

tamsulosin hydrochloride (.4 mg/1)

Linked Drug Pages (1)

Tamsulosin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "82b44507-051f-4892-a0b7-ed3955c2f72f", "openfda": {"upc": ["0382009025100"], "unii": ["11SV1951MR"], "rxcui": ["863669"], "spl_set_id": ["12ba3063-a134-41e2-8447-45933d4f0f58"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (82009-025-10)", "package_ndc": "82009-025-10", "marketing_start_date": "20220820"}], "brand_name": "Tamsulosin Hydrochloride", "product_id": "82009-025_82b44507-051f-4892-a0b7-ed3955c2f72f", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "82009-025", "generic_name": "Tamsulosin Hydrochloride", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tamsulosin Hydrochloride", "active_ingredients": [{"name": "TAMSULOSIN HYDROCHLORIDE", "strength": ".4 mg/1"}], "application_number": "ANDA078225", "marketing_category": "ANDA", "marketing_start_date": "20220820", "listing_expiration_date": "20261231"}