Home NDC 71335-0504 Triamterene and Hydrochlorothiazide
Product NDC 71335-0504
11-digit product format 713350504
Labeler code 71335
Product ID 71335-0504_30ae3951-4e7b-4509-a2bd-fe2cd51d446c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Triamterene and Hydrochlorothiazide
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA201407
Marketing category ANDA
Marketing start 2011-12-09
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201407-001 AB
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.
Product history page 1 of 2 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201407-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB 2011-12-09 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 25 mg/1 HYDROCHLOROTHIAZIDE 37.5 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 71335-0504-1 Triamterene and Hydrochlorothiazide 100 in 1 BOTTLE CAPSULE 100 5 71335-0504-2 Triamterene and Hydrochlorothiazide 30 in 1 BOTTLE CAPSULE 30 5 71335-0504-3 Triamterene and Hydrochlorothiazide 60 in 1 BOTTLE CAPSULE 60 5 71335-0504-4 Triamterene and Hydrochlorothiazide 90 in 1 BOTTLE CAPSULE 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0504 TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK] 5 Current NDC, Legacy NDC, 4 package rows 20240117_6517777a-e49e-4da6-b34b-66ec58cceff7.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TRIAMTERENE AND HYDROCHLOROTHIAZIDE TRIAMTERENE AND HYDROCHLOROTHIAZIDE Chartwell RX, LLC 261dd83f-8048-488f-8b71-c4abd9692720 2025-12-10 Adverse reactions Exact identifier application applno (ANDA): 201407 application number: ANDA201407 Triamterene and Hydrochlorothiazide TRIAMTERENE AND HYDROCHLOROTHIAZIDE A-S Medication Solutions d692b189-1b06-46f5-a257-758a7dede863 2024-01-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201407 application number: ANDA201407 Triamterene and Hydrochlorothiazide TRIAMTERENE AND HYDROCHLOROTHIAZIDE Bryant Ranch Prepack 6517777a-e49e-4da6-b34b-66ec58cceff7 2024-01-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201407 application number: ANDA201407 ndc (product): 71335-0504 Triamterene and Hydrochlorothiazide TRIAMTERENE AND HYDROCHLOROTHIAZIDE Bryant Ranch Prepack 8cc154c2-2ed2-4d7c-95a5-e2946393270c 2023-05-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201407 application number: ANDA201407 Triamterene and Hydrochlorothiazide TRIAMTERENE AND HYDROCHLOROTHIAZIDE Proficient Rx LP 189ad040-07e9-42a5-854c-67633367da74 2023-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201407 application number: ANDA201407
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71335-0504-1 71335050401 100 CAPSULE in 1 BOTTLE (71335-0504-1) 100 capsule 2021-12-27 0000-00-00 No No Current 71335-0504-2 71335050402 30 CAPSULE in 1 BOTTLE (71335-0504-2) 30 capsule 2020-08-05 0000-00-00 No No Current 71335-0504-3 71335050403 60 CAPSULE in 1 BOTTLE (71335-0504-3) 60 capsule 2019-04-23 0000-00-00 No No Current 71335-0504-4 71335050404 90 CAPSULE in 1 BOTTLE (71335-0504-4) 90 capsule 2020-08-05 0000-00-00 No No Current