tamsulosin hydrochloride

Generic: tamsulosin hydrochloride

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tamsulosin hydrochloride
Generic Name tamsulosin hydrochloride
Labeler zydus lifesciences limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tamsulosin hydrochloride .4 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 65841-695
Product ID 65841-695_b05d1829-8334-4145-b49d-6074624bc499
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078225
Listing Expiration 2026-12-31
Marketing Start 2010-04-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65841695
Hyphenated Format 65841-695

Supplemental Identifiers

RxCUI
863669
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
  • 100 CAPSULE in 1 BOTTLE (65841-695-01)
  • 500 CAPSULE in 1 BOTTLE (65841-695-05)
  • 30 CAPSULE in 1 BOTTLE (65841-695-06)
  • 1000 CAPSULE in 1 BOTTLE (65841-695-10)
  • 60 CAPSULE in 1 BOTTLE (65841-695-14)
  • 90 CAPSULE in 1 BOTTLE (65841-695-16)
  • 10 BLISTER PACK in 1 CARTON (65841-695-77) / 10 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (7)

Ingredients (1)

tamsulosin hydrochloride (.4 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "b05d1829-8334-4145-b49d-6074624bc499", "openfda": {"unii": ["11SV1951MR"], "rxcui": ["863669"], "spl_set_id": ["276c7e26-f86a-46b9-b626-ceef76b729a4"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (65841-695-01)", "package_ndc": "65841-695-01", "marketing_start_date": "20100427"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (65841-695-05)", "package_ndc": "65841-695-05", "marketing_start_date": "20100427"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (65841-695-06)", "package_ndc": "65841-695-06", "marketing_start_date": "20100427"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (65841-695-10)", "package_ndc": "65841-695-10", "marketing_start_date": "20100427"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (65841-695-14)", "package_ndc": "65841-695-14", "marketing_start_date": "20100427"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (65841-695-16)", "package_ndc": "65841-695-16", "marketing_start_date": "20100427"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65841-695-77)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "65841-695-77", "marketing_start_date": "20100427"}], "brand_name": "Tamsulosin Hydrochloride", "product_id": "65841-695_b05d1829-8334-4145-b49d-6074624bc499", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "65841-695", "generic_name": "Tamsulosin Hydrochloride", "labeler_name": "Zydus Lifesciences Limited", "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": "20100427", "listing_expiration_date": "20261231"}