FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
72162-2509
11-digit product format
721622509
Labeler code
72162
Product ID
72162-2509_4e3d8221-3319-47d8-ba8d-1187c6dc6372
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
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
72162-2509-1Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE100100
72162-2509-5Tamsulosin Hydrochloride500 in 1 BOTTLECAPSULE500100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2509-1EA - Each72162-25097d6e10a9-028f-47a1-9c35-0232d785786912025-07-08
72162-2509-5EA - Each72162-25098c3f3e35-ddcb-474e-8e85-66cdb22bfbc512025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2509TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20250524_36b8c36f-22e5-40f5-a99a-411115f13df4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN36b8c36f-22e5-40f5-a99a-411115f13df4100
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD36b8c36f-22e5-40f5-a99a-411115f13df4100
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY36b8c36f-22e5-40f5-a99a-411115f13df4100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2509-172162250901100 CAPSULE in 1 BOTTLE (72162-2509-1) 100 capsule2025-05-23NoNoHistorical
72162-2509-572162250905500 CAPSULE in 1 BOTTLE (72162-2509-5) 500 capsule2025-05-23NoNoHistorical