FDA.reportPublic FDA data

NDC 60505-2657-01 - Triamterene and Hydrochlorothiazide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
60505-2657
Requested NDC
60505-2657-01
Package NDCs from labels
60505-2657-1, 60505-2657-5, 60505-2657-7, 60505-2657-01
Manufacturer
Apotex Corp. | Apotex Inc.
Effective date
2026-02-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Triamterene and Hydrochlorothiazide Tablets, 37.5 mg/ 25 mg and 75 mg/50 mgApotex Corp. | Apotex Inc.2026-02-17HUMAN PRESCRIPTION DRUG LABEL
Triamterene and Hydrochlorothiazide - Northwind Health Company, LLCNorthwind Health Company, LLC2026-01-01HUMAN PRESCRIPTION DRUG LABEL
Triamterene and Hydrochlorothiazide - Bryant Ranch PrepackBryant Ranch Prepack2025-09-12HUMAN PRESCRIPTION DRUG LABEL
Triamterene and Hydrochlorothiazide - A-S Medication SolutionsA-S Medication Solutions2023-02-04HUMAN PRESCRIPTION DRUG LABEL
Triamterene and Hydrochlorothiazide - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2020-11-12HUMAN PRESCRIPTION DRUG LABEL
Triamterene and Hydrochlorothiazide Tablets, 37.5 mg/ 25 mg and 75 mg/50 mgPreferred Pharmaceuticals, Inc.2020-06-01HUMAN PRESCRIPTION DRUG LABEL
Triamterene and Hydrochlorothiazide Tablets, 37.5 mg/ 25 mg and 75 mg/50 mgNuCare Pharmaceuticals,Inc.2017-12-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-2657-1Triamterene and Hydrochlorothiazide100 in 1 BOTTLETABLET10010
60505-2657-5Triamterene and Hydrochlorothiazide500 in 1 BOTTLETABLET50010
60505-2657-7Triamterene and Hydrochlorothiazide7000 in 1 BOTTLETABLET700010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2657TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]7Current NDC, Legacy NDC, 3 package rows20241004_bd6c3495-ec70-908b-482a-a979506659e9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2657-1EA - Each60505-265727051dbe-be18-4397-b230-74d9142c0dc412012-07-24
60505-2657-5EA - Each60505-26572c5f8ced-9db8-4e27-94c8-3536ad44ae6612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1
TRIAMTERENEACTIVE INGREDIENTWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1
TRIAMTERENEACTIVE MOIETYWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 28 · 554 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.5ee165a3-39a4-4d12-aff2-a6fb3309ce392026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310818
unii: WS821Z52LQ
unii: 0J48LPH2TH
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAvKARE1b303136-dccd-178b-e063-6394a90a35f82026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.7dc3414b-dcb5-4b11-bca7-c0fa3f474aea2026-09-03Boxed warning, Adverse reactionsExact identifier
unii: WS821Z52LQ
unii: 0J48LPH2TH
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEUmedica Laboratories USA Inc.55d6aee1-01ca-4791-8404-386664b4ab072026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEEdenbridge Pharmaceuticals LLC.295532b5-65c8-40c3-8d27-cfd334d128022026-08-28Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEREMEDYREPACK INC.57ffeef7-bfa8-4f92-aadc-23cd000226072026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.f20fd735-30c7-4f89-8ceb-b6186646eea62026-08-27Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.8e0683e2-5473-4246-97ae-b71c21c39ac72026-08-26Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.8bc8d5e2-a974-64ed-e053-2a95a90a83402026-08-25Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack53221419-204c-40a2-9ec3-8e4b994dd39d2026-08-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions12ba7eba-1874-41b6-aff5-7baba8b999842026-08-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack154cb1d2-9fb2-4c8d-90de-6a8062a8d1ba2026-08-19Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEANI Pharmaceuticals, Inc.a26bcf78-6515-4e9f-b2dc-4aaa8ec1a82c2026-08-12Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDETeva Pharmaceuticals USA, Inc.27d52b23-e3e2-4339-b00e-cd0fec43ffbb2026-08-11Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSREMEDYREPACK INC.3bea11a3-eb07-46b2-9b91-f8a48a2f3b7e2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.fd07d24c-6db1-4f6b-b226-68abba3a33212026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.446e6998-01f6-4de0-be57-7fecf5448e952026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.b9ee689a-ea12-435d-b01c-70d45891e62f2026-08-06Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.31a3d1cb-0f52-4818-965d-7584374bb23e2026-08-06Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSProficient Rx LP43a4d6dd-bcca-412c-b051-ed470208ddb62026-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.