FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
71205-217
11-digit product format
712050217
Labeler code
71205
Product ID
71205-217_668d5539-1561-457c-9a7c-38784a9b5c66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-217-07Tamsulosin Hydrochloride7 in 1 BOTTLECAPSULE73
71205-217-14Tamsulosin Hydrochloride14 in 1 BOTTLECAPSULE143
71205-217-30Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE303
71205-217-60Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE603
71205-217-90Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-217-14EA - Each71205-21797c9fea9-9930-467d-9111-5e7633a5682812020-04-20
71205-217-30EA - Each71205-217e9a05386-c495-46c0-8bbf-9b9f7299c6ca12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-217TAMSULOSIN HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 5 package rows20200206_06b44e53-c6e7-4e12-a8fd-572d092cfa70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN06b44e53-c6e7-4e12-a8fd-572d092cfa703
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD06b44e53-c6e7-4e12-a8fd-572d092cfa703
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY06b44e53-c6e7-4e12-a8fd-572d092cfa703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-217-07712050217077 CAPSULE in 1 BOTTLE (71205-217-07) 7 capsule2017-08-110000-00-00NoNoCurrent
71205-217-147120502171414 CAPSULE in 1 BOTTLE (71205-217-14) 14 capsule2020-02-050000-00-00NoNoCurrent
71205-217-307120502173030 CAPSULE in 1 BOTTLE (71205-217-30) 30 capsule2017-08-110000-00-00NoNoCurrent
71205-217-607120502176060 CAPSULE in 1 BOTTLE (71205-217-60) 60 capsule2017-08-110000-00-00NoNoCurrent
71205-217-907120502179090 CAPSULE in 1 BOTTLE (71205-217-90) 90 capsule2017-08-110000-00-00NoNoCurrent