Tamsulosin Hydrochloride

Product NDC
82009-025
11-digit product format
820090025
Labeler code
82009
Product ID
82009-025_82b44507-051f-4892-a0b7-ed3955c2f72f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Quallent Pharmaceuticals Health LLC
Application
ANDA078225
Marketing category
ANDA
Marketing start
2022-08-20
Substance
TAMSULOSIN HYDROCHLORIDE
Active strength
.4 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tamsulosin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAMSULOSIN HYDROCHLORIDE.4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii11SV1951MR
Rxcui863669

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82009-025-10Tamsulosin Hydrochloride1000 in 1 BOTTLECAPSULE10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-025-10EA - Each82009-0251222fac3-be33-4d35-8006-bcfc226c74ea12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-025TAMSULOSIN HYDROCHLORIDE CAPSULE [QUALLENT PHARMACEUTICALS HEALTH LLC]2Current NDC, Legacy NDC, 1 package rows20230919_12ba3063-a134-41e2-8447-45933d4f0f58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN12ba3063-a134-41e2-8447-45933d4f0f582
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD12ba3063-a134-41e2-8447-45933d4f0f582
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY12ba3063-a134-41e2-8447-45933d4f0f582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82009-025-10820090025101000 CAPSULE in 1 BOTTLE (82009-025-10) 1000 capsule2022-08-200000-00-00NoNoCurrent