TRIAMTERENE AND HYDROCHLOROTHIAZIDE

Product NDC
61919-338
11-digit product format
619190338
Labeler code
61919
Product ID
61919-338_c80d15e2-fc5c-8d53-e053-2a95a90a8d67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Dosage form
TABLET
Route
ORAL
Labeler
DirectRX
Application
ANDA071251
Marketing category
ANDA
Marketing start
2015-12-01
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE; TRIAMTERENE
Active strength
25 mg/1; mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
b2ea36e8-564d-01b9-8552-a327d058eb0fProduct name220200203
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-338-302025-01-30C16284748780-12cef2736-b5a8-d83d-e063-dadaa90ab31fTRIAMTERENE AND HYDROCHLOROTHIAZIDE
61919-338-902025-01-30C16284748780-12cef2736-b5a8-d83d-e063-dadaa90ab31fTRIAMTERENE AND HYDROCHLOROTHIAZIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-338-30TRIAMTERENE AND HYDROCHLOROTHIAZIDE30 in 1 BOTTLETABLET304
61919-338-90TRIAMTERENE AND HYDROCHLOROTHIAZIDE90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-338-30EA - Each61919-338955912e0-5019-4133-9f60-99d654d08bf612017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-338TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [DIRECTRX]4Legacy NDC, 2 package rows20210727_25dc3437-0042-74a1-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310812triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN25dc3437-0042-74a1-e054-00144ff88e884
310812hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral TabletSCD25dc3437-0042-74a1-e054-00144ff88e884
310812HCTZ 25 MG / triamterene 37.5 MG Oral TabletSY25dc3437-0042-74a1-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-338-306191903383030 TABLET in 1 BOTTLE (61919-338-30) 30 tablet2015-12-010000-00-00NoNoCurrent
61919-338-906191903389090 TABLET in 1 BOTTLE (61919-338-90) 90 tablet2015-12-010000-00-00NoNoCurrent