FDA.reportPublic FDA data

Dutasteride and Tamsulosin Hydrochloride

Product NDC
42291-031
11-digit product format
422910031
Labeler code
42291
Product ID
42291-031_48483bec-9af4-f1bd-e063-6294a90a8d84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dutasteride and Tamsulosin Hydrochloride Capsules
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA202509
Marketing category
ANDA
Marketing start
2023-11-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dutasteride and Tamsulosin Hydrochloride
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-031-30Dutasteride and Tamsulosin Hydrochloride30 in 1 BOTTLECAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-031-30EA - Each42291-0319c00f7e6-580b-472f-886d-e15f58f9d4e112023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-031DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES) CAPSULE [AVKARE]1Current NDC, 1 package rows20231116_0a334eb9-cacf-f213-e063-6394a90a46da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
42291-031-304229100313030 CAPSULE in 1 BOTTLE (42291-031-30) 30 capsule2023-11-15NoNoCurrent