Triamterene and Hydrochlorothiazide

Product NDC
10135-581
11-digit product format
101350581
Labeler code
10135
Product ID
10135-581_d6121404-16a8-4270-919d-97bed516e72b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamterene and Hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA201407
Marketing category
ANDA
Marketing start
2014-10-01
Marketing end
0000-00-00
Substance
TRIAMTERENE; HYDROCHLOROTHIAZIDE
Active strength
38 mg/1; mg/1
Pharmacologic classes
Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
10135-581-012021-01-29C16284748780-1ba0f9c33-5363-a910-e053-dadaa90a0b85Triamterene and Hydrochlorothiazide Capsules
10135-581-102021-01-29C16284748780-1ba0f9c33-5363-a910-e053-dadaa90a0b85Triamterene and Hydrochlorothiazide Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-581-01Triamterene and Hydrochlorothiazide100 in 1 BOTTLECAPSULE1003
10135-581-10Triamterene and Hydrochlorothiazide1000 in 1 BOTTLECAPSULE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-581-01EA - Each10135-581ed5cfc68-c6a3-4e75-952e-99f6c84aa31b12016-03-04
10135-581-10EA - Each10135-581b3c1966f-c146-4a22-a3b2-6f34d459b37b12016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-581TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MARLEX PHARMACEUTICALS INC]3Legacy NDC, 2 package rows20191213_0cf90605-e7b7-42b4-a0ee-80639b3bcdeb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198316hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral CapsulePSN0cf90605-e7b7-42b4-a0ee-80639b3bcdeb3
198316hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral CapsuleSCD0cf90605-e7b7-42b4-a0ee-80639b3bcdeb3
198316HCTZ 25 MG / triamterene 37.5 MG Oral CapsuleSY0cf90605-e7b7-42b4-a0ee-80639b3bcdeb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-581-0110135058101100 in 1 BOTTLEHistorical
10135-581-10101350581101000 in 1 BOTTLEHistorical