Home NDC 50090-5801 triamterene and hydrochlorothiazide
Product NDC 50090-5801
11-digit product format 500905801
Labeler code 50090
Product ID 50090-5801_f1a0f370-c447-4acb-9b93-9f4302400c5d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name triamterene and hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA208360
Marketing category ANDA
Marketing start 2018-09-04
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 50MG;75MG TABLET / ORAL AB 2018-06-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 86 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 2026-09-14 22:38:34 2026-08 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208360-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG TABLET / ORAL AB 2018-06-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A208360-002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 50MG;75MG TABLET / ORAL AB 2018-06-29 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
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 310812 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-5801-0 triamterene and hydrochlorothiazide 30 in 1 BOTTLE TABLET 30 6 50090-5801-1 triamterene and hydrochlorothiazide 100 in 1 BOTTLE TABLET 100 6 50090-5801-2 triamterene and hydrochlorothiazide 90 in 1 BOTTLE TABLET 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5801 TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS] 6 Current NDC, Legacy NDC, 3 package rows 20231125_839216fd-5eac-4550-8baa-ad77b91c5de7.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.
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 50090-5801-0 50090580100 30 TABLET in 1 BOTTLE (50090-5801-0) 30 tablet 2021-10-14 0000-00-00 No No Current 50090-5801-1 50090580101 100 TABLET in 1 BOTTLE (50090-5801-1) 100 tablet 2021-10-14 0000-00-00 No No Current 50090-5801-2 50090580102 90 TABLET in 1 BOTTLE (50090-5801-2) 90 tablet 2021-10-14 0000-00-00 No No Current