FDA.reportPublic FDA data

Dutasteride and Tamsulosin Hydrochloride

Product NDC
10370-280
11-digit product format
103700280
Labeler code
10370
Product ID
10370-280_79eff189-e6e9-477e-beb6-568046fb5043
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dutasteride and Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA202509
Marketing category
ANDA
Marketing start
2015-11-18
Substance
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
Active strength
.5; .4 mg/1; mg/1
Pharmacologic classes
5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA], 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
Dutasteride and Tamsulosin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DUTASTERIDE.5 mg/1
TAMSULOSIN HYDROCHLORIDE.4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO0J6XJN02I, 11SV1951MR
Rxcui996097

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313
15cfa3ee-23c6-c9fd-f216-95d9676ee575Product name920180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10370-280-092022-10-05C16284748780-1e4f33bdf-a4cb-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES. DUTASTERIDE and TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 2010
10370-280-112022-10-05C16284748780-1e4f33bdf-a4cb-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES. DUTASTERIDE and TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 2010
10370-280-092022-07-29C16284748780-1e4f33bdf-a4cb-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES. DUTASTERIDE and TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 2010
10370-280-112022-07-29C16284748780-1e4f33bdf-a4cb-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES. DUTASTERIDE and TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 2010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10370-280-09Dutasteride and Tamsulosin Hydrochloride90 in 1 BOTTLECAPSULE9018
10370-280-11Dutasteride and Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10370-280-09EA - Each10370-2800bcc8590-6ddd-4c8b-9e16-a84a3c7bcd8812015-12-02
10370-280-11EA - Each10370-2806403531d-e95b-414a-b1ef-6a4589dbfc0212015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DUTASTERIDEACTIVE INGREDIENTO0J6XJN02IDUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRDUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
DUTASTERIDEACTIVE MOIETYO0J6XJN02IDUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
TAMSULOSINACTIVE MOIETYG3P28OML5IDUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
AMMONIAINACTIVE INGREDIENT5138Q19F1XDUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KDUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESINACTIVE INGREDIENTU72Q2I8C85DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
ETHYLCELLULOSE (10 MPA.S)INACTIVE INGREDIENT3DYK7UYZ62DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
GELATININACTIVE INGREDIENT2G86QN327LDUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UDUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
POLYVINYL ACETATE PHTHALATEINACTIVE INGREDIENT58QVG85GW3DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
SHELLACINACTIVE INGREDIENT46N107B71ODUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
SUCROSEINACTIVE INGREDIENTC151H8M554DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
TALCINACTIVE INGREDIENT7SEV7J4R1UDUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [PAR PHARMACEUTICAL]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10370-280DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULE [ENDO USA, INC.]18Current NDC, Legacy NDC, 2 package rows20240913_8c6031b3-b6a8-4ec7-b0d3-286f50d29353.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996097dutasteride 0.5 MG / tamsulosin HCl 0.4 MG Oral CapsulePSN8c6031b3-b6a8-4ec7-b0d3-286f50d2935318
996097dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD8c6031b3-b6a8-4ec7-b0d3-286f50d2935318
996097dutasteride 0.5 MG / tamsulosin HCl 0.4 MG Oral CapsulePSN0a334eb9-cacf-f213-e063-6394a90a46da2
996097dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral CapsuleSCD0a334eb9-cacf-f213-e063-6394a90a46da2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10370-280-091037002800990 CAPSULE in 1 BOTTLE (10370-280-09) 90 capsule2015-11-180000-00-00NoNoCurrent
10370-280-111037002801130 CAPSULE in 1 BOTTLE (10370-280-11) 30 capsule2015-11-180000-00-00NoNoCurrent