FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
65841-695
11-digit product format
658410695
Labeler code
65841
Product ID
65841-695_b05d1829-8334-4145-b49d-6074624bc499
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Lifesciences Limited
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
65841-695-01Tamsulosin Hydrochloride100 in 1 BOTTLECAPSULE1009
65841-695-05Tamsulosin Hydrochloride500 in 1 BOTTLECAPSULE5009
65841-695-06Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE309
65841-695-10Tamsulosin Hydrochloride1000 in 1 BOTTLECAPSULE10009
65841-695-14Tamsulosin Hydrochloride60 in 1 BOTTLECAPSULE609
65841-695-16Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE909
65841-695-77Tamsulosin Hydrochloride10 in 1 CARTONCAPSULE109
65841-695-77Tamsulosin Hydrochloride10 in 1 BLISTER PACKCAPSULE109

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [CADILA HEALTHCARE LIMITED]3
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [CADILA HEALTHCARE LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [CADILA HEALTHCARE LIMITED]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTAMSULOSIN HYDROCHLORIDE CAPSULE [CADILA HEALTHCARE LIMITED]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTAMSULOSIN HYDROCHLORIDE CAPSULE [CADILA HEALTHCARE LIMITED]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATAMSULOSIN HYDROCHLORIDE CAPSULE [CADILA HEALTHCARE LIMITED]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TAMSULOSIN HYDROCHLORIDE CAPSULE [CADILA HEALTHCARE LIMITED]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [CADILA HEALTHCARE LIMITED]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [CADILA HEALTHCARE LIMITED]3
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [CADILA HEALTHCARE LIMITED]3
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656TAMSULOSIN HYDROCHLORIDE CAPSULE [CADILA HEALTHCARE LIMITED]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTAMSULOSIN HYDROCHLORIDE CAPSULE [CADILA HEALTHCARE LIMITED]3
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [CADILA HEALTHCARE LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [CADILA HEALTHCARE LIMITED]3
TRIACETININACTIVE INGREDIENTXHX3C3X673TAMSULOSIN HYDROCHLORIDE CAPSULE [CADILA HEALTHCARE LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-695TAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED]9Current NDC, Legacy NDC, 8 package rows20240815_276c7e26-f86a-46b9-b626-ceef76b729a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSN276c7e26-f86a-46b9-b626-ceef76b729a49
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD276c7e26-f86a-46b9-b626-ceef76b729a49
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSY276c7e26-f86a-46b9-b626-ceef76b729a49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-695-0165841069501100 CAPSULE in 1 BOTTLE (65841-695-01) 100 capsule2010-04-270000-00-00NoNoCurrent
65841-695-0565841069505500 CAPSULE in 1 BOTTLE (65841-695-05) 500 capsule2010-04-270000-00-00NoNoCurrent
65841-695-066584106950630 CAPSULE in 1 BOTTLE (65841-695-06) 30 capsule2010-04-270000-00-00NoNoCurrent
65841-695-10658410695101000 CAPSULE in 1 BOTTLE (65841-695-10) 1000 capsule2010-04-270000-00-00NoNoCurrent
65841-695-146584106951460 CAPSULE in 1 BOTTLE (65841-695-14) 60 capsule2010-04-270000-00-00NoNoCurrent
65841-695-166584106951690 CAPSULE in 1 BOTTLE (65841-695-16) 90 capsule2010-04-270000-00-00NoNoCurrent
65841-695-776584106957710 BLISTER PACK in 1 CARTON (65841-695-77) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2010-04-270000-00-00NoNoCurrent