FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
0615-8055
11-digit product format
006158055
Labeler code
0615
Product ID
0615-8055_b5eec9b2-57b2-44f8-8117-3af64069e4d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA202433
Marketing category
ANDA
Marketing start
2013-04-30
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
0615-8055-05Tamsulosin Hydrochloride15 in 1 BLISTER PACKCAPSULE1517
0615-8055-07Tamsulosin Hydrochloride7 in 1 BLISTER PACKCAPSULE717
0615-8055-14Tamsulosin Hydrochloride14 in 1 BLISTER PACKCAPSULE1417
0615-8055-28Tamsulosin Hydrochloride28 in 1 BLISTER PACKCAPSULE2817
0615-8055-30Tamsulosin Hydrochloride6 in 1 BOX, UNIT-DOSECAPSULE617
0615-8055-30Tamsulosin Hydrochloride5 in 1 BLISTER PACKCAPSULE517
0615-8055-39Tamsulosin Hydrochloride30 in 1 BLISTER PACKCAPSULE3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8055TAMSULOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]17Current NDC, Legacy NDC, 7 package rows20240921_503d080c-9db3-434a-add6-c7d0e5a0ab2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN503d080c-9db3-434a-add6-c7d0e5a0ab2e17
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD503d080c-9db3-434a-add6-c7d0e5a0ab2e17
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY503d080c-9db3-434a-add6-c7d0e5a0ab2e17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8055-050061580550515 CAPSULE in 1 BLISTER PACK (0615-8055-05) 15 capsule2013-04-300000-00-00NoNoCurrent
0615-8055-07006158055077 CAPSULE in 1 BLISTER PACK (0615-8055-07) 7 capsule2018-09-270000-00-00NoNoCurrent
0615-8055-140061580551414 CAPSULE in 1 BLISTER PACK (0615-8055-14) 14 capsule2023-08-24NoNoCurrent
0615-8055-280061580552828 CAPSULE in 1 BLISTER PACK (0615-8055-28) 28 capsule2024-04-25NoNoCurrent
0615-8055-30006158055306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8055-30) / 5 CAPSULE in 1 BLISTER PACK6 blister pack2019-03-280000-00-00NoNoCurrent
0615-8055-390061580553930 CAPSULE in 1 BLISTER PACK (0615-8055-39) 30 capsule2013-04-300000-00-00NoNoCurrent