tamsulosin hydrochloride

Generic: tamsulosin hydrochloride

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tamsulosin hydrochloride
Generic Name tamsulosin hydrochloride
Labeler zydus pharmaceuticals usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tamsulosin hydrochloride .4 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-132
Product ID 68382-132_ee9d9efd-0c79-4993-bfd7-d4c30e20bddd
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 68382132
Hyphenated Format 68382-132

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 (68382-132-01)
  • 500 CAPSULE in 1 BOTTLE (68382-132-05)
  • 30 CAPSULE in 1 BOTTLE (68382-132-06)
  • 1000 CAPSULE in 1 BOTTLE (68382-132-10)
  • 60 CAPSULE in 1 BOTTLE (68382-132-14)
  • 90 CAPSULE in 1 BOTTLE (68382-132-16)
  • 100 BLISTER PACK in 1 CARTON (68382-132-77) / 1 CAPSULE in 1 BLISTER PACK (68382-132-30)
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": "ee9d9efd-0c79-4993-bfd7-d4c30e20bddd", "openfda": {"unii": ["11SV1951MR"], "rxcui": ["863669"], "spl_set_id": ["300be29a-c56d-4daa-ba89-f207c281ea20"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68382-132-01)", "package_ndc": "68382-132-01", "marketing_start_date": "20100427"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (68382-132-05)", "package_ndc": "68382-132-05", "marketing_start_date": "20100427"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68382-132-06)", "package_ndc": "68382-132-06", "marketing_start_date": "20100427"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (68382-132-10)", "package_ndc": "68382-132-10", "marketing_start_date": "20100427"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (68382-132-14)", "package_ndc": "68382-132-14", "marketing_start_date": "20100427"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (68382-132-16)", "package_ndc": "68382-132-16", "marketing_start_date": "20100427"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (68382-132-77)  / 1 CAPSULE in 1 BLISTER PACK (68382-132-30)", "package_ndc": "68382-132-77", "marketing_start_date": "20100427"}], "brand_name": "Tamsulosin Hydrochloride", "product_id": "68382-132_ee9d9efd-0c79-4993-bfd7-d4c30e20bddd", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "68382-132", "generic_name": "Tamsulosin Hydrochloride", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "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"}