Triamterene and Hydrochlorothiazide

Product NDC
68788-8624
11-digit product format
687888624
Labeler code
68788
Product ID
68788-8624_b7589c66-17d0-4b44-a504-d30fbc734808
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamterene and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA216211
Marketing category
ANDA
Marketing start
2024-04-08
Substance
HYDROCHLOROTHIAZIDE; TRIAMTERENE
Active strength
50; 75 mg/1; mg/1
Pharmacologic classes
Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Triamterene and Hydrochlorothiazide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE50 mg/1
TRIAMTERENE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH, WS821Z52LQ
Rxcui310818

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8624-1Triamterene and Hydrochlorothiazide100 in 1 BOTTLETABLET1002
68788-8624-3Triamterene and Hydrochlorothiazide30 in 1 BOTTLETABLET302
68788-8624-6Triamterene and Hydrochlorothiazide60 in 1 BOTTLETABLET602
68788-8624-9Triamterene and Hydrochlorothiazide90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8624-1EA - Each68788-862492382911-98dd-4686-b843-b90d780d2c9912024-06-10
68788-8624-3EA - Each68788-8624de92125d-8777-44eb-9621-6e983c01a48412024-06-10
68788-8624-6EA - Each68788-86244b24970e-49a1-4422-9c15-c60a79c1c9ff12024-06-10
68788-8624-9EA - Each68788-8624e0008e45-92ce-4b4c-b84f-6f27c5b1533012024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8624TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20240413_5fc69fbf-c2d2-41ef-99bb-62a76ef74db2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310818triamterene 75 MG / hydroCHLOROthiazide 50 MG Oral TabletPSN5fc69fbf-c2d2-41ef-99bb-62a76ef74db22
310818hydrochlorothiazide 50 MG / triamterene 75 MG Oral TabletSCD5fc69fbf-c2d2-41ef-99bb-62a76ef74db22
310818HCTZ 50 MG / triamterene 75 MG Oral TabletSY5fc69fbf-c2d2-41ef-99bb-62a76ef74db22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8624-168788862401100 TABLET in 1 BOTTLE (68788-8624-1) 100 tablet2024-04-08NoNoHistorical
68788-8624-36878886240330 TABLET in 1 BOTTLE (68788-8624-3) 30 tablet2024-04-08NoNoHistorical
68788-8624-66878886240660 TABLET in 1 BOTTLE (68788-8624-6) 60 tablet2024-04-08NoNoHistorical
68788-8624-96878886240990 TABLET in 1 BOTTLE (68788-8624-9) 90 tablet2024-04-08NoNoHistorical