FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
63187-358
11-digit product format
631870358
Labeler code
63187
Product ID
63187-358_a9fd0947-15a1-45d0-94f7-1c08933122a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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
63187-358-07Tamsulosin Hydrochloride07 in 1 BOTTLECAPSULE075
63187-358-30Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE305
63187-358-60Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE605
63187-358-90Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-358-07EA - Each63187-35877b49835-f99d-44bb-b3f3-211dc1c6977512023-12-05
63187-358-30EA - Each63187-358da5530c8-6f93-4894-8a40-2892ba1bb82612017-03-06
63187-358-90EA - Each63187-35857e765cd-da46-4d22-a395-769de9078bd712017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-358TAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20220715_7275902e-6832-4e71-997a-d1f7fc1c6a11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN7275902e-6832-4e71-997a-d1f7fc1c6a115
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD7275902e-6832-4e71-997a-d1f7fc1c6a115
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY7275902e-6832-4e71-997a-d1f7fc1c6a115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-358-07631870358077 CAPSULE in 1 BOTTLE (63187-358-07) 7 capsule2017-10-020000-00-00NoNoCurrent
63187-358-306318703583030 CAPSULE in 1 BOTTLE (63187-358-30) 30 capsule2016-12-010000-00-00NoNoCurrent
63187-358-606318703586060 CAPSULE in 1 BOTTLE (63187-358-60) 60 capsule2016-12-010000-00-00NoNoCurrent
63187-358-906318703589090 CAPSULE in 1 BOTTLE (63187-358-90) 90 capsule2016-12-010000-00-00NoNoCurrent