FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
50268-740
11-digit product format
502680740
Labeler code
50268
Product ID
50268-740_41c4deb3-2dcf-b17a-e063-6294a90ad2be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA207405
Marketing category
ANDA
Marketing start
2018-01-17
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
50268-740-01Tamsulosin Hydrochloride100 in 1 BOXCAPSULE10011
50268-740-11Tamsulosin Hydrochloride1 in 1 BLISTER PACKCAPSULE111
50268-740-15Tamsulosin Hydrochloride50 in 1 BOX, UNIT-DOSECAPSULE5011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-740-01EA - Each50268-740d2dc1b0d-b70e-4428-9a17-07a2740186d712025-12-16
50268-740-11EA - Each50268-740b6c8c492-bbd4-4677-80fb-c2a061bdfda112018-03-08
50268-740-15EA - Each50268-740354ae719-106e-422f-afe3-78645693680b12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-740TAMSULOSIN HYDROCHLORIDE CAPSULE [AVPAK]10Current NDC, Legacy NDC, 3 package rows20240110_62fa7fdf-c588-6f79-e053-2a91aa0a4c19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN62fa7fdf-c588-6f79-e053-2a91aa0a4c1911
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD62fa7fdf-c588-6f79-e053-2a91aa0a4c1911
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY62fa7fdf-c588-6f79-e053-2a91aa0a4c1911
863669tamsulosin HCl 0.4 MG Oral CapsulePSN1e044a8a-c3ee-defc-e063-6394a90a60611
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD1e044a8a-c3ee-defc-e063-6394a90a60611
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY1e044a8a-c3ee-defc-e063-6394a90a60611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-740-0150268074001100 BLISTER PACK in 1 BOX (50268-740-01) / 1 CAPSULE in 1 BLISTER PACK (50268-740-11) 100 blister pack2025-10-22NoNoHistorical
50268-740-11502680740111 in 1 BLISTER PACKHistorical
50268-740-155026807401550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-740-15) / 1 CAPSULE in 1 BLISTER PACK (50268-740-11) 50 blister pack2018-01-170000-00-00NoNoCurrent