FDA.reportPublic FDA data

Triamterene and Hydrochlorothiazide

Product NDC
72578-090
11-digit product format
725780090
Labeler code
72578
Product ID
72578-090_ba702c00-5dc6-4545-bde9-ff7dbb7fd1a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamterene and Hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA208358
Marketing category
ANDA
Marketing start
2020-02-21
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
HYDROCHLOROTHIAZIDE25 mg/1
TRIAMTERENE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH, WS821Z52LQ
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
72578-090-01Triamterene and Hydrochlorothiazide100 in 1 BOTTLECAPSULE1004
72578-090-05Triamterene and Hydrochlorothiazide500 in 1 BOTTLECAPSULE5004
72578-090-10Triamterene and Hydrochlorothiazide1000 in 1 BOTTLECAPSULE10004
72578-090-30Triamterene and Hydrochlorothiazide10 in 1 BLISTER PACKCAPSULE104
72578-090-77Triamterene and Hydrochlorothiazide10 in 1 CARTONCAPSULE104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-090-01EA - Each72578-0901e6e8741-ed3d-462b-b8e0-f10d8a8b173c12021-02-05
72578-090-10EA - Each72578-0909462a17c-537f-43a8-b50a-09809b2cc44a12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-090TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [VIONA PHARMACEUTICALS INC]4Current NDC, Legacy NDC, 5 package rows20231101_9925ab75-e3b7-43b7-888e-a2c8763240ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198316hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral CapsulePSN5ca13106-f68b-4894-aca2-03e74fff350c102
198316hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral CapsuleSCD5ca13106-f68b-4894-aca2-03e74fff350c102
198316HCTZ 25 MG / triamterene 37.5 MG Oral CapsuleSY5ca13106-f68b-4894-aca2-03e74fff350c102
198316hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral CapsulePSN9925ab75-e3b7-43b7-888e-a2c8763240ba4
198316hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral CapsuleSCD9925ab75-e3b7-43b7-888e-a2c8763240ba4
198316HCTZ 25 MG / triamterene 37.5 MG Oral CapsuleSY9925ab75-e3b7-43b7-888e-a2c8763240ba4
198316hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral CapsulePSNcba87d5b-9302-7b2c-e053-2a95a90a7f9d3
198316hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral CapsulePSN08f3885e-dfde-79e4-e063-6394a90a4c093
198316hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral CapsuleSCD08f3885e-dfde-79e4-e063-6394a90a4c093
198316hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral CapsuleSCDcba87d5b-9302-7b2c-e053-2a95a90a7f9d3
198316HCTZ 25 MG / triamterene 37.5 MG Oral CapsuleSY08f3885e-dfde-79e4-e063-6394a90a4c093
198316HCTZ 25 MG / triamterene 37.5 MG Oral CapsuleSYcba87d5b-9302-7b2c-e053-2a95a90a7f9d3
198316hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral CapsulePSN7dc3414b-dcb5-4b11-bca7-c0fa3f474aea2
198316hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral CapsulePSN1fff8245-2b65-4ab1-aaa2-6bbbc6ac5fe82
198316hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral CapsuleSCD7dc3414b-dcb5-4b11-bca7-c0fa3f474aea2
198316hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral CapsuleSCD1fff8245-2b65-4ab1-aaa2-6bbbc6ac5fe82
198316HCTZ 25 MG / triamterene 37.5 MG Oral CapsuleSY7dc3414b-dcb5-4b11-bca7-c0fa3f474aea2
198316HCTZ 25 MG / triamterene 37.5 MG Oral CapsuleSY1fff8245-2b65-4ab1-aaa2-6bbbc6ac5fe82
198316hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral CapsulePSNde5e7c85-5bf5-5b5f-e053-2995a90a1fba1
198316hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral CapsulePSNd9fe1367-e725-4527-b515-95851d270b181
198316hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral CapsulePSN8857b70b-861d-44f8-a671-78c06c83c0291
198316hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral CapsuleSCD8857b70b-861d-44f8-a671-78c06c83c0291
198316hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral CapsuleSCDd9fe1367-e725-4527-b515-95851d270b181
198316hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral CapsuleSCDde5e7c85-5bf5-5b5f-e053-2995a90a1fba1
198316HCTZ 25 MG / triamterene 37.5 MG Oral CapsuleSYd9fe1367-e725-4527-b515-95851d270b181
198316HCTZ 25 MG / triamterene 37.5 MG Oral CapsuleSY8857b70b-861d-44f8-a671-78c06c83c0291
198316HCTZ 25 MG / triamterene 37.5 MG Oral CapsuleSYde5e7c85-5bf5-5b5f-e053-2995a90a1fba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-090-0172578009001100 CAPSULE in 1 BOTTLE (72578-090-01) 100 capsule2020-02-210000-00-00NoNoCurrent
72578-090-0572578009005500 CAPSULE in 1 BOTTLE (72578-090-05) 500 capsule2020-02-210000-00-00NoNoCurrent
72578-090-10725780090101000 CAPSULE in 1 BOTTLE (72578-090-10) 1000 capsule2020-02-210000-00-00NoNoCurrent
72578-090-307257800903010 in 1 BLISTER PACKHistorical
72578-090-777257800907710 BLISTER PACK in 1 CARTON (72578-090-77) / 10 CAPSULE in 1 BLISTER PACK (72578-090-30) 10 blister pack2020-02-210000-00-00NoNoCurrent