Tamsulosin Hydrochloride

Product NDC
0904-7383
11-digit product format
009047383
Labeler code
0904
Product ID
0904-7383_dbf1ae34-50e3-4c54-8e4f-fef014455f3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7383-61Tamsulosin Hydrochloride100 in 1 CARTONCAPSULE1003
0904-7383-61Tamsulosin Hydrochloride1 in 1 BLISTER PACKCAPSULE13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7383-61EA - Each0904-7383255df97a-10f2-4598-ad4c-f223ae2dcdef12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7383TAMSULOSIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]2Current NDC, 2 package rows20241020_f8302a6e-b8da-4931-a279-b49e37943816.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNf8302a6e-b8da-4931-a279-b49e379438163
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf8302a6e-b8da-4931-a279-b49e379438163
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYf8302a6e-b8da-4931-a279-b49e379438163
863669tamsulosin HCl 0.4 MG Oral CapsulePSN0e3206ba-db3e-40b3-b46b-c7ae4703fdea2
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD0e3206ba-db3e-40b3-b46b-c7ae4703fdea2
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY0e3206ba-db3e-40b3-b46b-c7ae4703fdea2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7383-6100904738361100 BLISTER PACK in 1 CARTON (0904-7383-61) / 1 CAPSULE in 1 BLISTER PACK100 blister pack2023-10-02NoNoHistorical