Tamsulosin Hydrochloride

Product NDC
63629-4346
11-digit product format
636294346
Labeler code
63629
Product ID
63629-4346_660d7436-8f1d-466b-b8d5-c67e5e2cdfe7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078225
Marketing category
ANDA
Marketing start
2010-04-27
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
63629-4346-1Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE3011
63629-4346-2Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE10011
63629-4346-3Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE6011
63629-4346-4Tamsulosin Hydrochloride10 in 1 BOTTLECAPSULE1011
63629-4346-5Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE9011
63629-4346-6Tamsulosin Hydrochloride180 in 1 BOTTLECAPSULE18011
63629-4346-7Tamsulosin Hydrochloride7 in 1 BOTTLECAPSULE711
63629-4346-8Tamsulosin Hydrochloride15 in 1 BOTTLECAPSULE1511
63629-4346-9Tamsulosin Hydrochloride120 in 1 BOTTLECAPSULE12011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4
TRIACETININACTIVE INGREDIENTXHX3C3X673TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4346TAMSULOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]11Current NDC, 9 package rows20240310_e9372720-bd02-e4a6-0afd-42fe0c661c00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNe9372720-bd02-e4a6-0afd-42fe0c661c0011
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDe9372720-bd02-e4a6-0afd-42fe0c661c0011
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYe9372720-bd02-e4a6-0afd-42fe0c661c0011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-4346-16362943460130 CAPSULE in 1 BOTTLE (63629-4346-1) 30 capsule2024-03-08NoNoCurrent
63629-4346-263629434602100 CAPSULE in 1 BOTTLE (63629-4346-2) 100 capsule2024-03-08NoNoCurrent
63629-4346-36362943460360 CAPSULE in 1 BOTTLE (63629-4346-3) 60 capsule2024-03-08NoNoCurrent
63629-4346-46362943460410 CAPSULE in 1 BOTTLE (63629-4346-4) 10 capsule2024-03-08NoNoCurrent
63629-4346-56362943460590 CAPSULE in 1 BOTTLE (63629-4346-5) 90 capsule2024-03-08NoNoCurrent
63629-4346-663629434606180 CAPSULE in 1 BOTTLE (63629-4346-6) 180 capsule2024-03-08NoNoCurrent
63629-4346-7636294346077 CAPSULE in 1 BOTTLE (63629-4346-7) 7 capsule2024-03-08NoNoCurrent
63629-4346-86362943460815 CAPSULE in 1 BOTTLE (63629-4346-8) 15 capsule2024-03-08NoNoCurrent
63629-4346-963629434609120 CAPSULE in 1 BOTTLE (63629-4346-9) 120 capsule2024-03-08NoNoCurrent