Tamsulosin Hydrochloride

Product NDC
53808-0691
11-digit product format
538080691
Labeler code
53808
Product ID
53808-0691_dca3de0d-f025-4602-af83-efd391b8623b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA078225
Marketing category
ANDA
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
TAMSULOSIN HYDROCHLORIDE
Active strength
0 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0691-2Tamsulosin Hydrochloride60 in 1 BLISTER PACKCAPSULE601

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0691TAMSULOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20140415_4ef1a932-b5b2-4ea7-a625-388dd78f9058.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN4ef1a932-b5b2-4ea7-a625-388dd78f90581
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD4ef1a932-b5b2-4ea7-a625-388dd78f90581
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY4ef1a932-b5b2-4ea7-a625-388dd78f90581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0691-25380806910260 in 1 BLISTER PACKHistorical