Home NDC 52817-365 Triamterene
Product NDC 52817-365
11-digit product format 528170365
Labeler code 52817
Product ID 52817-365_79343fce-fab3-4847-9bd2-09ae1b363827
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Triamterene Capsules
Dosage form CAPSULE
Route ORAL
Labeler TRUPHARMA LLC
Application ANDA211581
Marketing category ANDA
Marketing start 2018-12-12
Substance TRIAMTERENE
Active strength 100 mg/1
Pharmacologic classes Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC]
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 42 .
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 A211581-001 TRIAMTERENE TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 A211581-002 TRIAMTERENE TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19
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 · 82 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 2026-08-18 06:07:40 2026-07 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211581-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2019-08-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211581-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2019-08-19 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Triamterene
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIAMTERENE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WS821Z52LQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198312 Internal RxNorm lookup 198313 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 52817-365-10 Triamterene 100 in 1 BOTTLE CAPSULE 100 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52817-365 TRIAMTERENE (TRIAMTERENE CAPSULES) CAPSULE [TRUPHARMA LLC] 7 Current NDC, Legacy NDC, 1 package rows 20241206_fea50328-b3d5-4300-8c67-82cda0a975b7.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 · 2 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 52817-365-10 52817036510 100 CAPSULE in 1 BOTTLE (52817-365-10) 100 capsule 2018-12-12 0000-00-00 No No Current