FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
72865-282
11-digit product format
728650282
Labeler code
72865
Product ID
72865-282_cef0532b-bdf6-44e8-85a7-f302aa853949
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc
Application
ANDA214730
Marketing category
ANDA
Marketing start
2024-09-10
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
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72865-282-01Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE1003
72865-282-05Tamsulosin Hydrochloride500 in 1 BOTTLECAPSULE5003
72865-282-90Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-282-05EA - Each72865-2821b82e398-ec79-4cd9-8c32-f56c7606a6db12025-08-11
72865-282-90EA - Each72865-28245c54db4-5e1c-4dba-97f9-8d514dc15bbe12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-282TAMSULOSIN HYDROCHLORIDE CAPSULE [XLCARE PHARMACEUTICALS, INC]3Current NDC, 3 package rows20250406_9108b999-4b99-469d-99a8-5ef0fa4ca00a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN9108b999-4b99-469d-99a8-5ef0fa4ca00a3
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD9108b999-4b99-469d-99a8-5ef0fa4ca00a3
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY9108b999-4b99-469d-99a8-5ef0fa4ca00a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72865-282-0172865028201100 CAPSULE in 1 BOTTLE (72865-282-01) 100 capsule2024-09-10NoNoHistorical
72865-282-0572865028205500 CAPSULE in 1 BOTTLE (72865-282-05) 500 capsule2025-02-26NoNoHistorical
72865-282-907286502829090 CAPSULE in 1 BOTTLE (72865-282-90) 90 capsule2025-02-26NoNoHistorical