FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
43063-725
11-digit product format
430630725
Labeler code
43063
Product ID
43063-725_4900206d-2c3a-1940-e063-6394a90a8b0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
43063-725-30Tamsulosin Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE3019
43063-725-90Tamsulosin Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-725-30EA - Each43063-7258cceabab-9a6b-486c-b516-9fb0efb255fa12016-12-07
43063-725-90EA - Each43063-72524dee603-c326-4294-bb56-7c8256a0e4ed12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-725TAMSULOSIN HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 2 package rows20240224_f543f5d1-3348-4066-99a4-7a00aee1530d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNf543f5d1-3348-4066-99a4-7a00aee1530d19
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf543f5d1-3348-4066-99a4-7a00aee1530d19
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYf543f5d1-3348-4066-99a4-7a00aee1530d19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-725-304306307253030 CAPSULE in 1 BOTTLE, PLASTIC (43063-725-30) 30 capsule2016-10-310000-00-00NoNoCurrent
43063-725-904306307259090 CAPSULE in 1 BOTTLE, PLASTIC (43063-725-90) 90 capsule2018-02-140000-00-00NoNoCurrent