FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
0115-8211
11-digit product format
001158211
Labeler code
0115
Product ID
0115-8211_e62d078e-2896-4acd-bcaa-c21e855e66e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TAMSULOSIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA090377
Marketing category
ANDA
Marketing start
2025-04-01
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
0115-8211-01Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-8211-01EA - Each0115-821152031579-e9ae-4d73-8e46-9c43d03c0dcc12012-07-24
0115-8211-03EA - Each0115-82119ae2168d-987e-4acf-872a-a453317708ce12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
AMMONIAINACTIVE INGREDIENT5138Q19F1XTAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BTAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHTAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYTAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1STAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JTAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)INACTIVE INGREDIENT5KY68S2577TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
SHELLACINACTIVE INGREDIENT46N107B71OTAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
SUCROSEINACTIVE INGREDIENTC151H8M554TAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XTAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BTAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHTAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYTAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1STAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JTAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)INACTIVE INGREDIENT5KY68S2577TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OTAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554TAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-8211TAMSULOSIN HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]9Current NDC, 1 package rows20250419_c3ae55dd-6a0e-4f3a-82b6-2448e0545550.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNc3ae55dd-6a0e-4f3a-82b6-2448e05455509
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDc3ae55dd-6a0e-4f3a-82b6-2448e05455509
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYc3ae55dd-6a0e-4f3a-82b6-2448e05455509
863669tamsulosin HCl 0.4 MG Oral CapsulePSNdda1de08-d3c3-49c7-bd3c-5842f65d56623
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDdda1de08-d3c3-49c7-bd3c-5842f65d56623
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYdda1de08-d3c3-49c7-bd3c-5842f65d56623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0115-8211-0100115821101100 CAPSULE in 1 BOTTLE (0115-8211-01) 100 capsule2025-04-01NoNoHistorical