FDA.reportPublic FDA data

Jalyn

Product NDC
80725-809
11-digit product format
807250809
Labeler code
80725
Product ID
80725-809_bc6c62ea-da7b-4c27-a88e-c80cfcd7856d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DUTASTERIDE and TAMSULOSIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Waylis Therapeutics
Application
NDA022460
Marketing category
NDA
Marketing start
2024-03-01
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
Jalyn
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, 996101

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313
15cfa3ee-23c6-c9fd-f216-95d9676ee575Product name920180814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80725-809-13Jalyn30 in 1 BOTTLE, PLASTICCAPSULE304
80725-809-59Jalyn90 in 1 BOTTLE, PLASTICCAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80725-809-13EA - Each80725-8097df03cdf-74ca-45ee-8dbd-c46b02cd824d12025-05-14
80725-809-59EA - Each80725-809b1550cd1-e102-45b6-a8a5-5d300243dc5912025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80725-809JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [WAYLIS THERAPEUTICS]3Current NDC, 2 package rows20240719_aab9a2d4-5328-40f3-986f-e7753a928bc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996097dutasteride 0.5 MG / tamsulosin HCl 0.4 MG Oral CapsulePSNaab9a2d4-5328-40f3-986f-e7753a928bc04
996101Jalyn 0.5 MG / 0.4 MG Oral CapsulePSNaab9a2d4-5328-40f3-986f-e7753a928bc04
996101dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral Capsule [Jalyn]SBDaab9a2d4-5328-40f3-986f-e7753a928bc04
996097dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDaab9a2d4-5328-40f3-986f-e7753a928bc04
996101Jalyn (dutasteride 0.5 MG / tamsulosin HCl 0.4 MG) Oral CapsuleSYaab9a2d4-5328-40f3-986f-e7753a928bc04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80725-809-138072508091330 CAPSULE in 1 BOTTLE, PLASTIC (80725-809-13) 30 capsule2024-03-01NoNoCurrent
80725-809-598072508095990 CAPSULE in 1 BOTTLE, PLASTIC (80725-809-59) 90 capsule2024-03-01NoNoCurrent