Triamterene

Product NDC
72162-2265
11-digit product format
721622265
Labeler code
72162
Product ID
72162-2265_3c23af4c-0c83-46c0-8408-21a238b0aa8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamterene Capsules
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211581
Marketing category
ANDA
Marketing start
2018-12-12
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
2027-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211581-001TRIAMTERENETRIAMTERENE50MGCAPSULE / ORALAB2019-08-19
A211581-002TRIAMTERENETRIAMTERENE100MGCAPSULE / ORALAB2019-08-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A211581-001AB
A211581-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-19caaa826d4ba7…
2026-08-18 06:07:402026-07A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211581-001TRIAMTERENE50MGCAPSULE / ORALAB2019-08-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211581-002TRIAMTERENE100MGCAPSULE / ORALAB2019-08-19bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211581-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211581-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211581-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211581-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211581-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211581-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211581-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211581-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211581-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211581-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211581-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211581-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211581-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211581-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211581-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211581-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211581-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211581-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211581-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211581-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211581-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211581-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211581-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211581-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211581-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211581-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211581-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211581-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211581-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211581-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211581-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211581-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211581-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211581-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211581-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211581-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211581-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211581-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211581-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211581-002AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Triamterene
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMTERENE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WS821Z52LQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198313Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
93c2a15e-c8c0-429f-8085-f8b647c39dcfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
b2ea36e8-564d-01b9-8552-a327d058eb0fProduct name220200203
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2265-1Triamterene100 in 1 BOTTLECAPSULE100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2265-1EA - Each72162-2265dd49b164-a136-435f-8eb6-a1450890acf812024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2265TRIAMTERENE (TRIAMTERENE CAPSULES) CAPSULE [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20250309_93c2a15e-c8c0-429f-8085-f8b647c39dcf.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TriamtereneTRIAMTERENE CAPSULESBryant Ranch Prepack93c2a15e-c8c0-429f-8085-f8b647c39dcf2026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211581
application number: ANDA211581
ndc (product): 72162-2265
TriamtereneTRIAMTERENE CAPSULESTRUPHARMA LLCfea50328-b3d5-4300-8c67-82cda0a975b72025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211581
application number: ANDA211581

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198313triamterene 50 MG Oral CapsulePSN93c2a15e-c8c0-429f-8085-f8b647c39dcf102
198313triamterene 50 MG Oral CapsuleSCD93c2a15e-c8c0-429f-8085-f8b647c39dcf102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2265-172162226501100 CAPSULE in 1 BOTTLE (72162-2265-1) 100 capsule2026-03-18NoNoCurrent