triamterene

Product NDC: 66993-831
11-digit product format: 669930831
Labeler code: 66993
Product ID: 66993-831_d7ce0a55-ba61-4995-8141-43c4736d4be9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Triamterene
Dosage form: CAPSULE
Route: ORAL
Labeler: Prasco Laboratories
Application: NDA013174
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2019-08-13
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 1.

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
N013174-001	DYRENIUM	TRIAMTERENE	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982
N013174-002	DYRENIUM	TRIAMTERENE	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N013174-001	AB
N013174-002	AB

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	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N013174-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013174-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013174-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013174-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N013174-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013174-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013174-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013174-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013174-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013174-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013174-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013174-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013174-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013174-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013174-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013174-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013174-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013174-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N013174-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N013174-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013174-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013174-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013174-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013174-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013174-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013174-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N013174-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N013174-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013174-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013174-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N013174-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N013174-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N013174-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N013174-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N013174-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N013174-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N013174-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N013174-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N013174-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N013174-002	AB	1	`782e0a99824c…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a09c2212-1dd5-4fbe-ad09-2a57aeabcaea	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
b2ea36e8-564d-01b9-8552-a327d058eb0f	Product name	2	20200203
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66993-831-02	triamterene	100 in 1 BOTTLE	CAPSULE	100		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-831-02	EA - Each	66993-831	c556d185-5431-495a-9234-20e952208966	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66993-831	TRIAMTERENE CAPSULE TRIAMTERENE CAPSULE [PRASCO LABORATORIES]	13	Current NDC, Legacy NDC, 1 package rows	20230707_a09c2212-1dd5-4fbe-ad09-2a57aeabcaea.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dyrenium	TRIAMTERENE	Advanz Pharma (US) Corp.	ebb177c0-d45d-4443-a85a-e76bd9931a42	2024-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 013174 application number: NDA013174
triamterene	TRIAMTERENE	Prasco Laboratories	a09c2212-1dd5-4fbe-ad09-2a57aeabcaea	2023-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 013174 application number: NDA013174 ndc (product): 66993-831

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WS821Z52LQ	TRIAMTERENE	396-01-0	TRIAMTERENE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198312	triamterene 100 MG Oral Capsule	PSN	a09c2212-1dd5-4fbe-ad09-2a57aeabcaea	13
198313	triamterene 50 MG Oral Capsule	PSN	a09c2212-1dd5-4fbe-ad09-2a57aeabcaea	13
198312	triamterene 100 MG Oral Capsule	SCD	a09c2212-1dd5-4fbe-ad09-2a57aeabcaea	13
198313	triamterene 50 MG Oral Capsule	SCD	a09c2212-1dd5-4fbe-ad09-2a57aeabcaea	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66993-831-02	66993083102	100 CAPSULE in 1 BOTTLE (66993-831-02)	100 capsule	2019-08-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Triamterene USP Capsules 50 mg and 100 mg potassium-sparing diuretic	Prasco Laboratories	2023-07-03	Human Prescription Drug Label	13