Dyrenium

Product NDC: 65197-003
11-digit product format: 651970003
Labeler code: 65197
Product ID: 65197-003_96d12576-d968-41bc-ad64-fd3812e09f25
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Triamterene
Dosage form: CAPSULE
Route: ORAL
Labeler: WellSpring Pharmaceutical Corporation
Application: NDA013174
Marketing category: NDA
Marketing start: 1999-01-01
Marketing end: 2020-01-31
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: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	65197-003		D	Discontinued by firm		2026-08-10
excluded package	package	65197-003	65197-003-01	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65197-003-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65197-003-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65197-003-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65197-003-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65197-003-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65197-003-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65197-003-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65197-003-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65197-003-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65197-003-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65197-003-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65197-003-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65197-003-01	EA - Each	65197-003	411dd26b-f0cf-4b03-9dd9-339537176ee5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRIAMTERENE	ACTIVE INGREDIENT	WS821Z52LQ	DYRENIUM (TRIAMTERENE) CAPSULE [WELLSPRING PHARMACEUTICAL CORPORATION]	8
TRIAMTERENE	ACTIVE MOIETY	WS821Z52LQ	DYRENIUM (TRIAMTERENE) CAPSULE [WELLSPRING PHARMACEUTICAL CORPORATION]	8
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	DYRENIUM (TRIAMTERENE) CAPSULE [WELLSPRING PHARMACEUTICAL CORPORATION]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DYRENIUM (TRIAMTERENE) CAPSULE [WELLSPRING PHARMACEUTICAL CORPORATION]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DYRENIUM (TRIAMTERENE) CAPSULE [WELLSPRING PHARMACEUTICAL CORPORATION]	8
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	DYRENIUM (TRIAMTERENE) CAPSULE [WELLSPRING PHARMACEUTICAL CORPORATION]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DYRENIUM (TRIAMTERENE) CAPSULE [WELLSPRING PHARMACEUTICAL CORPORATION]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DYRENIUM (TRIAMTERENE) CAPSULE [WELLSPRING PHARMACEUTICAL CORPORATION]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DYRENIUM (TRIAMTERENE) CAPSULE [WELLSPRING PHARMACEUTICAL CORPORATION]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DYRENIUM (TRIAMTERENE) CAPSULE [WELLSPRING PHARMACEUTICAL CORPORATION]	8

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

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DYRENIUM ® (triamterene USP) Capsules 50 mg and 100 mg potassium-sparing diuretic	WellSpring Pharmaceutical Corporation	2013-05-14	HUMAN PRESCRIPTION DRUG LABEL	8