JALYN

Product NDC
0173-0809
11-digit product format
001730809
Labeler code
0173
Product ID
0173-0809_d4997425-dc8a-4f1d-9508-0fe326591fe9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dutasteride and tamsulosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
GlaxoSmithKline LLC
Application
NDA022460
Marketing category
NDA
Marketing start
2010-06-21
Marketing end
2024-03-31
Substance
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
Active strength
1 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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
15cfa3ee-23c6-c9fd-f216-95d9676ee575Product name920180814
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0809-13EA - Each0173-08099d2d062f-0d64-4cf0-bad4-fc7a1371451212012-07-24
0173-0809-59EA - Each0173-0809aad0be62-4246-4beb-b008-64981fbde5c112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DUTASTERIDEACTIVE INGREDIENTO0J6XJN02IJALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRJALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
DUTASTERIDEACTIVE MOIETYO0J6XJN02IJALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
TAMSULOSINACTIVE MOIETYG3P28OML5IJALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KJALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESINACTIVE INGREDIENTU72Q2I8C85JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJJALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UJALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTJALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LJALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXJALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOJALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UJALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPJALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMJALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996097dutasteride 0.5 MG / tamsulosin HCl 0.4 MG Oral CapsulePSNf96c6acd-4d02-4ece-bd54-2d5a35aab7f51
996101Jalyn 0.5 MG / 0.4 MG Oral CapsulePSNf96c6acd-4d02-4ece-bd54-2d5a35aab7f51
996101dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral Capsule [Jalyn]SBDf96c6acd-4d02-4ece-bd54-2d5a35aab7f51
996097dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDf96c6acd-4d02-4ece-bd54-2d5a35aab7f51
996101Jalyn (dutasteride 0.5 MG / tamsulosin HCl 0.4 MG) Oral CapsuleSYf96c6acd-4d02-4ece-bd54-2d5a35aab7f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0173-0809-130017308091330 CAPSULE in 1 BOTTLE (0173-0809-13) 30 capsule2010-06-210000-00-00NoNoCurrent
0173-0809-590017308095990 CAPSULE in 1 BOTTLE (0173-0809-59) 90 capsule2010-06-210000-00-00NoNoCurrent