FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
71335-1784
11-digit product format
713351784
Labeler code
71335
Product ID
71335-1784_bb82e90f-d822-46ed-96d7-984186923c85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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
71335-1784-0Tamsulosin Hydrochloride3 in 1 BOTTLECAPSULE3103
71335-1784-1Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE30103
71335-1784-2Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE100103
71335-1784-3Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE60103
71335-1784-4Tamsulosin Hydrochloride10 in 1 BOTTLECAPSULE10103
71335-1784-5Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE90103
71335-1784-6Tamsulosin Hydrochloride180 in 1 BOTTLECAPSULE180103
71335-1784-7Tamsulosin Hydrochloride7 in 1 BOTTLECAPSULE7103
71335-1784-8Tamsulosin Hydrochloride15 in 1 BOTTLECAPSULE15103
71335-1784-9Tamsulosin Hydrochloride120 in 1 BOTTLECAPSULE120103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1784TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 10 package rows20240504_59d0e07c-0018-4681-beb2-cb1c8e2637ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN59d0e07c-0018-4681-beb2-cb1c8e2637ee103
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD59d0e07c-0018-4681-beb2-cb1c8e2637ee103
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY59d0e07c-0018-4681-beb2-cb1c8e2637ee103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1784-0713351784003 CAPSULE in 1 BOTTLE (71335-1784-0) 3 capsule2021-03-10NoNoHistorical
71335-1784-17133517840130 CAPSULE in 1 BOTTLE (71335-1784-1) 30 capsule2021-03-100000-00-00NoNoCurrent
71335-1784-271335178402100 CAPSULE in 1 BOTTLE (71335-1784-2) 100 capsule2021-03-100000-00-00NoNoCurrent
71335-1784-37133517840360 CAPSULE in 1 BOTTLE (71335-1784-3) 60 capsule2021-03-100000-00-00NoNoCurrent
71335-1784-47133517840410 CAPSULE in 1 BOTTLE (71335-1784-4) 10 capsule2021-03-100000-00-00NoNoCurrent
71335-1784-57133517840590 CAPSULE in 1 BOTTLE (71335-1784-5) 90 capsule2021-03-100000-00-00NoNoCurrent
71335-1784-671335178406180 CAPSULE in 1 BOTTLE (71335-1784-6) 180 capsule2021-03-100000-00-00NoNoCurrent
71335-1784-7713351784077 CAPSULE in 1 BOTTLE (71335-1784-7) 7 capsule2021-03-100000-00-00NoNoCurrent
71335-1784-87133517840815 CAPSULE in 1 BOTTLE (71335-1784-8) 15 capsule2021-03-100000-00-00NoNoCurrent
71335-1784-971335178409120 CAPSULE in 1 BOTTLE (71335-1784-9) 120 capsule2021-03-100000-00-00NoNoCurrent