tamsulosin hydrochloride

Generic: tamsulosin hydrochloride

Labeler: exelan pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

tamsulosin hydrochloride .4 mg/1

Manufacturer
EXELAN PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 76282-744
Product ID 76282-744_06b18b22-60b7-486b-a87c-17a2ae4cfe41
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078801
Listing Expiration 2026-12-31
Marketing Start 2024-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282744
Hyphenated Format 76282-744

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 ANDA078801 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .4 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (76282-744-05)
  • 90 CAPSULE in 1 BOTTLE (76282-744-90)
source: ndc

Packages (2)

76282-744-05 500 CAPSULE in 1 BOTTLE (76282-744-05) 76282-744-90 90 CAPSULE in 1 BOTTLE (76282-744-90)

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": "06b18b22-60b7-486b-a87c-17a2ae4cfe41", "openfda": {"unii": ["11SV1951MR"], "rxcui": ["863669"], "spl_set_id": ["db6cb771-2cff-40b7-a5ef-ea3cf2a3b461"], "manufacturer_name": ["EXELAN PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (76282-744-05)", "package_ndc": "76282-744-05", "marketing_start_date": "20240301"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76282-744-90)", "package_ndc": "76282-744-90", "marketing_start_date": "20250314"}], "brand_name": "Tamsulosin hydrochloride", "product_id": "76282-744_06b18b22-60b7-486b-a87c-17a2ae4cfe41", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "76282-744", "generic_name": "Tamsulosin hydrochloride", "labeler_name": "EXELAN PHARMACEUTICALS, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tamsulosin hydrochloride", "active_ingredients": [{"name": "TAMSULOSIN HYDROCHLORIDE", "strength": ".4 mg/1"}], "application_number": "ANDA078801", "marketing_category": "ANDA", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}