FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
71335-1538
11-digit product format
713351538
Labeler code
71335
Product ID
71335-1538_9f11a118-1a0e-4fa2-a6c0-1258f965c905
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207405
Marketing category
ANDA
Marketing start
2017-08-11
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
71335-1538-0Tamsulosin Hydrochloride3 in 1 BOTTLECAPSULE35
71335-1538-1Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE305
71335-1538-2Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE1005
71335-1538-3Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE605
71335-1538-4Tamsulosin Hydrochloride10 in 1 BOTTLECAPSULE105
71335-1538-5Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE905
71335-1538-6Tamsulosin Hydrochloride180 in 1 BOTTLECAPSULE1805
71335-1538-7Tamsulosin Hydrochloride7 in 1 BOTTLECAPSULE75
71335-1538-8Tamsulosin Hydrochloride15 in 1 BOTTLECAPSULE155
71335-1538-9Tamsulosin Hydrochloride120 in 1 BOTTLECAPSULE1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1538TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 10 package rows20240830_f185abfc-367d-45da-87c4-86d9f70bcd5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNf185abfc-367d-45da-87c4-86d9f70bcd5d5
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf185abfc-367d-45da-87c4-86d9f70bcd5d5
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYf185abfc-367d-45da-87c4-86d9f70bcd5d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1538-0713351538003 CAPSULE in 1 BOTTLE (71335-1538-0) 3 capsule2020-03-20NoNoHistorical
71335-1538-17133515380130 CAPSULE in 1 BOTTLE (71335-1538-1) 30 capsule2020-03-200000-00-00NoNoCurrent
71335-1538-271335153802100 CAPSULE in 1 BOTTLE (71335-1538-2) 100 capsule2020-03-200000-00-00NoNoCurrent
71335-1538-37133515380360 CAPSULE in 1 BOTTLE (71335-1538-3) 60 capsule2020-03-200000-00-00NoNoCurrent
71335-1538-47133515380410 CAPSULE in 1 BOTTLE (71335-1538-4) 10 capsule2020-03-200000-00-00NoNoCurrent
71335-1538-57133515380590 CAPSULE in 1 BOTTLE (71335-1538-5) 90 capsule2020-03-200000-00-00NoNoCurrent
71335-1538-671335153806180 CAPSULE in 1 BOTTLE (71335-1538-6) 180 capsule2020-03-200000-00-00NoNoCurrent
71335-1538-7713351538077 CAPSULE in 1 BOTTLE (71335-1538-7) 7 capsule2020-03-200000-00-00NoNoCurrent
71335-1538-87133515380815 CAPSULE in 1 BOTTLE (71335-1538-8) 15 capsule2020-03-200000-00-00NoNoCurrent
71335-1538-971335153809120 CAPSULE in 1 BOTTLE (71335-1538-9) 120 capsule2020-03-200000-00-00NoNoCurrent