Triamterene and Hydrochlorothiazide

Product NDC
63187-465
11-digit product format
631870465
Labeler code
63187
Product ID
63187-465_11589775-58be-49a6-befb-6d24fa830899
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamterene and Hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074821
Marketing category
ANDA
Marketing start
1997-06-05
Substance
HYDROCHLOROTHIAZIDE; TRIAMTERENE
Active strength
25; 37.5 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
TRIAMTERENE25 mg/1
HYDROCHLOROTHIAZIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWS821Z52LQ, 0J48LPH2TH
Rxcui198316

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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
63187-465-30Triamterene and Hydrochlorothiazide30 in 1 BOTTLECAPSULE303
63187-465-60Triamterene and Hydrochlorothiazide60 in 1 BOTTLECAPSULE603
63187-465-90Triamterene and Hydrochlorothiazide90 in 1 BOTTLECAPSULE903

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
TRIAMTERENEACTIVE INGREDIENTWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
TRIAMTERENEACTIVE MOIETYWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
GLYCINEINACTIVE INGREDIENTTE7660XO1CTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ETRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
SHELLACINACTIVE INGREDIENT46N107B71OTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-465TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20210114_f11598d2-87ee-4292-8631-c29c54f4dfa9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198316hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral CapsulePSNf11598d2-87ee-4292-8631-c29c54f4dfa93
198316hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral CapsuleSCDf11598d2-87ee-4292-8631-c29c54f4dfa93
198316HCTZ 25 MG / triamterene 37.5 MG Oral CapsuleSYf11598d2-87ee-4292-8631-c29c54f4dfa93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-465-306318704653030 CAPSULE in 1 BOTTLE (63187-465-30) 30 capsule2019-01-010000-00-00NoNoCurrent
63187-465-606318704656060 CAPSULE in 1 BOTTLE (63187-465-60) 60 capsule2019-01-010000-00-00NoNoCurrent
63187-465-906318704659090 CAPSULE in 1 BOTTLE (63187-465-90) 90 capsule2019-01-010000-00-00NoNoCurrent