Home NDC 33342-467 Triamterene and Hydrochlorothiazide
Product NDC 33342-467
11-digit product format 333420467
Labeler code 33342
Product ID 33342-467_96024781-b8d8-452f-ab9c-6c9ab07b34ea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Triamterene and Hydrochlorothiazide
Dosage form CAPSULE
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA214611
Marketing category ANDA
Marketing start 2025-01-28
Substance TRIAMTERENE; HYDROCHLOROTHIAZIDE
Active strength 37.5; 25 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214611-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG CAPSULE / ORAL 2025-01-28
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A214611-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL 2025-01-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214611-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL 2025-01-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214611-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL 2025-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214611-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL 2025-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214611-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL 2025-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214611-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2025-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214611-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2025-01-28 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214611-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL 2025-01-28 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214611-001 AB 1 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214611-001 AB 1 b8a1b40f171c…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Triamterene and Hydrochlorothiazide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIAMTERENE 37.5 mg/1 HYDROCHLOROTHIAZIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WS821Z52LQ Internal UNII lookup 0J48LPH2TH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198316 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33342-467-11 Triamterene and Hydrochlorothiazide 100 in 1 BOTTLE CAPSULE 100 2 33342-467-44 Triamterene and Hydrochlorothiazide 1000 in 1 BOTTLE CAPSULE 1000 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-467 TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MACLEODS PHARMACEUTICALS LIMITED] 2 Current NDC, 2 package rows 20250315_e05e3314-5520-4bbd-b7f0-623afd9ba569.zip
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 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 33342-467-11 33342046711 100 CAPSULE in 1 BOTTLE (33342-467-11) 100 capsule 2025-01-28 No No Current 33342-467-44 33342046744 1000 CAPSULE in 1 BOTTLE (33342-467-44) 1000 capsule 2025-01-28 No No Current