Home NDC 72888-504-01 Triamterene
Product NDC 72888-504
Requested package NDC 72888-504-01
11-digit product format 728880504
Labeler code 72888
Product ID 72888-504_5f49b458-1c48-add0-e063-6394a90a0a24
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Triamterene
Dosage form CAPSULE
Route ORAL
Labeler Advagen Pharma Ltd
Application ANDA220782
Marketing category ANDA
Marketing start 2026-10-28
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 A220782-001 TRIAMTERENE TRIAMTERENE 50MG CAPSULE / ORAL AB 2026-10-28 A220782-002 TRIAMTERENE TRIAMTERENE 100MG CAPSULE / ORAL AB 2026-10-28
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.
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 2026-11-14 07:37:17 2026-10 A220782-001 TRIAMTERENE 50MG CAPSULE / ORAL AB 2026-10-28 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A220782-002 TRIAMTERENE 100MG CAPSULE / ORAL AB 2026-10-28 d4dbc9d85df4…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-11-14 07:37:17 2026-10 A220782-001 AB 1 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A220782-002 AB 1 d4dbc9d85df4…
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
Listing expiration 2027-12-31 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72888-504-01 72888050401 100 CAPSULE in 1 BOTTLE (72888-504-01) 100 capsule 2026-10-28 No No Current