Tamsulosin Hydrochloride

Product NDC
67046-1015
11-digit product format
670461015
Labeler code
67046
Product ID
67046-1015_52bbd288-9556-e73c-e063-6294a90a1671
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Coupler LLC
Application
ANDA078225
Marketing category
ANDA
Marketing start
2026-05-26
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tamsulosin Hydrochloride
Listing expiration
2027-12-31

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
67046-1015-3Tamsulosin Hydrochloride30 in 1 BLISTER PACKCAPSULE301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN52bbe73b-43b6-3393-e063-6294a90a6dc61
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD52bbe73b-43b6-3393-e063-6294a90a6dc61
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY52bbe73b-43b6-3393-e063-6294a90a6dc61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1015-36704610150330 CAPSULE in 1 BLISTER PACK (67046-1015-3) 30 capsule2026-05-26NoNoCurrent