Home NDC 70377-138 Triamterene
Product NDC 70377-138
11-digit product format 703770138
Labeler code 70377
Product ID 70377-138_b3324943-f57a-665f-33ab-edc54e868427
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Triamterene
Dosage form CAPSULE
Route ORAL
Labeler Biocon Pharma Inc.
Application ANDA214768
Marketing category ANDA
Marketing start 2025-02-10
Substance TRIAMTERENE
Active strength 50 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 A214768-001 TRIAMTERENE TRIAMTERENE 50MG CAPSULE / ORAL AB 2022-07-06 A214768-002 TRIAMTERENE TRIAMTERENE 100MG CAPSULE / ORAL AB 2022-07-06
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 2 · 58 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 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2022-07-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2022-07-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2022-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2022-07-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2022-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2022-07-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2022-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2022-07-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2022-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2022-07-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2022-07-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2022-07-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2022-07-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2022-07-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2022-07-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2022-07-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL 2022-07-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL 2022-07-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL 2022-07-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL 2022-07-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL 2022-07-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL 2022-07-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL 2022-07-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL 2022-07-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL 2022-07-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL 2022-07-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL 2022-07-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL 2022-07-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL 2022-07-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL 2022-07-06 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL 2022-07-06 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL 2022-07-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL 2022-07-06 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL 2022-07-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL 2022-07-06 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL 2022-07-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL 2022-07-06 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL 2022-07-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214768-001 TRIAMTERENE 50MG CAPSULE / ORAL 2022-07-06 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214768-002 TRIAMTERENE 100MG CAPSULE / ORAL 2022-07-06 9b2671bbb829…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Triamterene
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIAMTERENE 50 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 70377-138-11 Triamterene 30 in 1 BOTTLE CAPSULE 30 2 70377-138-12 Triamterene 100 in 1 BOTTLE CAPSULE 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70377-138 TRIAMTERENE CAPSULE [BIOCON PHARMA INC. ] 2 Current NDC, 2 package rows 20250227_dcaa7b4d-9613-298a-5a39-f2032492096c.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 70377-138-11 70377013811 30 CAPSULE in 1 BOTTLE (70377-138-11) 30 capsule 2025-02-10 No No Current 70377-138-12 70377013812 100 CAPSULE in 1 BOTTLE (70377-138-12) 100 capsule 2025-02-10 No No Current