FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
33342-159
11-digit product format
333420159
Labeler code
33342
Product ID
33342-159_95b0ff14-97b3-4b8c-8545-f066a45c2f82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA204645
Marketing category
ANDA
Marketing start
2017-01-25
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
33342-159-07Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE304
33342-159-11Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE1004
33342-159-12Tamsulosin Hydrochloride10 in 1 BLISTER PACKCAPSULE104
33342-159-12Tamsulosin Hydrochloride10 in 1 CARTONCAPSULE104
33342-159-15Tamsulosin Hydrochloride500 in 1 BOTTLECAPSULE5004
33342-159-44Tamsulosin Hydrochloride1000 in 1 BOTTLECAPSULE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-159-11EA - Each33342-1599d9e08f8-dd74-4bca-88aa-518cb5d0bb5512017-07-07
33342-159-15EA - Each33342-15994ef4cb6-557d-4137-8a7d-3f6db3ab278112018-03-08
33342-159-44EA - Each33342-1593333e6ea-47bd-4f9f-8bdc-e4f3fbae149d12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-159TAMSULOSIN HYDROCHLORIDE CAPSULE [MACLEODS PHARMACEUTICALS LIMITED]4Current NDC, Legacy NDC, 6 package rows20221202_2912fbbc-89bf-4bf0-86fe-bd98f3168e84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN3533e74e-5706-f594-e063-6394a90ab8a7101
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD3533e74e-5706-f594-e063-6394a90ab8a7101
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY3533e74e-5706-f594-e063-6394a90ab8a7101
863669tamsulosin HCl 0.4 MG Oral CapsulePSNa3362c28-7caf-df91-e053-2995a90a3d0e7
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDa3362c28-7caf-df91-e053-2995a90a3d0e7
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYa3362c28-7caf-df91-e053-2995a90a3d0e7
863669tamsulosin HCl 0.4 MG Oral CapsulePSN2912fbbc-89bf-4bf0-86fe-bd98f3168e844
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD2912fbbc-89bf-4bf0-86fe-bd98f3168e844
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY2912fbbc-89bf-4bf0-86fe-bd98f3168e844
863669tamsulosin HCl 0.4 MG Oral CapsulePSN87618dfd-eae4-2532-e053-2a95a90a10a03
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD87618dfd-eae4-2532-e053-2a95a90a10a03
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY87618dfd-eae4-2532-e053-2a95a90a10a03
863669tamsulosin HCl 0.4 MG Oral CapsulePSNb85769ba-814e-1adb-e053-2a95a90a05562
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDb85769ba-814e-1adb-e053-2a95a90a05562
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYb85769ba-814e-1adb-e053-2a95a90a05562

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-159-073334201590730 CAPSULE in 1 BOTTLE (33342-159-07) 30 capsule2017-01-250000-00-00NoNoCurrent
33342-159-1133342015911100 CAPSULE in 1 BOTTLE (33342-159-11) 100 capsule2017-01-250000-00-00NoNoCurrent
33342-159-123334201591210 BLISTER PACK in 1 CARTON (33342-159-12) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2017-01-250000-00-00NoNoCurrent
33342-159-1533342015915500 CAPSULE in 1 BOTTLE (33342-159-15) 500 capsule2017-01-250000-00-00NoNoCurrent
33342-159-44333420159441000 CAPSULE in 1 BOTTLE (33342-159-44) 1000 capsule2017-01-250000-00-00NoNoCurrent