FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
71205-688
11-digit product format
712050688
Labeler code
71205
Product ID
71205-688_58cba3d8-bb57-4e64-a191-dc050904c896
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
71205-688-07Tamsulosin Hydrochloride7 in 1 BOTTLECAPSULE71
71205-688-14Tamsulosin Hydrochloride14 in 1 BOTTLECAPSULE141
71205-688-30Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE301
71205-688-60Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE601
71205-688-90Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-688-14EA - Each71205-688303806b7-f4d0-438e-97eb-71ea7bc2d31112022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-688TAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1Current NDC, Legacy NDC, 5 package rows20220825_58cba3d8-bb57-4e64-a191-dc050904c896.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN58cba3d8-bb57-4e64-a191-dc050904c8961
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD58cba3d8-bb57-4e64-a191-dc050904c8961
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY58cba3d8-bb57-4e64-a191-dc050904c8961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-688-07712050688077 CAPSULE in 1 BOTTLE (71205-688-07) 7 capsule2022-08-220000-00-00NoNoCurrent
71205-688-147120506881414 CAPSULE in 1 BOTTLE (71205-688-14) 14 capsule2022-08-220000-00-00NoNoCurrent
71205-688-307120506883030 CAPSULE in 1 BOTTLE (71205-688-30) 30 capsule2022-08-220000-00-00NoNoCurrent
71205-688-607120506886060 CAPSULE in 1 BOTTLE (71205-688-60) 60 capsule2022-08-220000-00-00NoNoCurrent
71205-688-907120506889090 CAPSULE in 1 BOTTLE (71205-688-90) 90 capsule2022-08-220000-00-00NoNoCurrent