FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
63187-371
11-digit product format
631870371
Labeler code
63187
Product ID
63187-371_148ad490-41a3-4be3-b33e-e5c7c551e561
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-371-07Tamsulosin Hydrochloride7 in 1 BOTTLECAPSULE74
63187-371-14Tamsulosin Hydrochloride14 in 1 BOTTLECAPSULE144
63187-371-30Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE304
63187-371-60Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE604
63187-371-90Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-371-07EA - Each63187-3711c0d904c-f657-4365-9862-13c09f610eaa12016-10-06
63187-371-30EA - Each63187-37146a95d35-d3f9-47f6-a973-0f1b93d551ea12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-371TAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 5 package rows20230204_25d5ceab-a04b-4cf0-bc48-3d0c6d8af006.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN25d5ceab-a04b-4cf0-bc48-3d0c6d8af0064
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD25d5ceab-a04b-4cf0-bc48-3d0c6d8af0064
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY25d5ceab-a04b-4cf0-bc48-3d0c6d8af0064

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-371-07631870371077 CAPSULE in 1 BOTTLE (63187-371-07) 7 capsule2016-09-010000-00-00NoNoCurrent
63187-371-146318703711414 CAPSULE in 1 BOTTLE (63187-371-14) 14 capsule2016-08-010000-00-00NoNoCurrent
63187-371-306318703713030 CAPSULE in 1 BOTTLE (63187-371-30) 30 capsule2016-09-010000-00-00NoNoCurrent
63187-371-606318703716060 CAPSULE in 1 BOTTLE (63187-371-60) 60 capsule2016-09-010000-00-00NoNoCurrent
63187-371-906318703719090 CAPSULE in 1 BOTTLE (63187-371-90) 90 capsule2016-09-010000-00-00NoNoCurrent