Dyrenium

Product NDC: 59212-002
11-digit product format: 592120002
Labeler code: 59212
Product ID: 59212-002_a617b947-1315-4f6e-8fd2-9697906de9ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Triamterene
Dosage form: CAPSULE
Route: ORAL
Labeler: Advanz Pharma (US) Corp.
Application: NDA013174
Marketing category: NDA
Marketing start: 1999-10-01
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 44.

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 · 88 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
2026-10-15 13:18:30	2026-09	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N013174-001	DYRENIUM	50MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N013174-002	DYRENIUM	100MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N013174-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N013174-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N013174-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N013174-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N013174-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N013174-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N013174-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N013174-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N013174-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N013174-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N013174-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N013174-002	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N013174-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N013174-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N013174-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N013174-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N013174-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N013174-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N013174-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N013174-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N013174-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N013174-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N013174-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N013174-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N013174-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N013174-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N013174-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N013174-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N013174-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N013174-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N013174-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N013174-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N013174-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N013174-002	AB	1	`f41ea6bd6efb…`

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: Dyrenium
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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198312	Internal RxNorm lookup
198313	Internal RxNorm lookup
208674	Internal RxNorm lookup
208675	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
ebb177c0-d45d-4443-a85a-e76bd9931a42	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
59212-002-01	Dyrenium	100 in 1 BOTTLE	CAPSULE	100		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59212-002-01	EA - Each	59212-002	25774587-2002-46b9-89cf-de57701688e7	1	2016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRIAMTERENE	ACTIVE INGREDIENT	WS821Z52LQ	DYRENIUM (TRIAMTERENE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]	1
TRIAMTERENE	ACTIVE MOIETY	WS821Z52LQ	DYRENIUM (TRIAMTERENE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	DYRENIUM (TRIAMTERENE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DYRENIUM (TRIAMTERENE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DYRENIUM (TRIAMTERENE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	DYRENIUM (TRIAMTERENE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DYRENIUM (TRIAMTERENE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DYRENIUM (TRIAMTERENE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DYRENIUM (TRIAMTERENE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DYRENIUM (TRIAMTERENE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59212-002	DYRENIUM (TRIAMTERENE) CAPSULE [ADVANZ PHARMA (US) CORP.]	11	Current NDC, Legacy NDC, 1 package rows	20241224_ebb177c0-d45d-4443-a85a-e76bd9931a42.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 ndc (product): 59212-002
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
208674	Dyrenium 100 MG Oral Capsule	PSN	ebb177c0-d45d-4443-a85a-e76bd9931a42	11
208675	Dyrenium 50 MG Oral Capsule	PSN	ebb177c0-d45d-4443-a85a-e76bd9931a42	11
198312	triamterene 100 MG Oral Capsule	PSN	ebb177c0-d45d-4443-a85a-e76bd9931a42	11
198313	triamterene 50 MG Oral Capsule	PSN	ebb177c0-d45d-4443-a85a-e76bd9931a42	11
208674	triamterene 100 MG Oral Capsule [Dyrenium]	SBD	ebb177c0-d45d-4443-a85a-e76bd9931a42	11
208675	triamterene 50 MG Oral Capsule [Dyrenium]	SBD	ebb177c0-d45d-4443-a85a-e76bd9931a42	11
198312	triamterene 100 MG Oral Capsule	SCD	ebb177c0-d45d-4443-a85a-e76bd9931a42	11
198313	triamterene 50 MG Oral Capsule	SCD	ebb177c0-d45d-4443-a85a-e76bd9931a42	11
208674	Dyrenium 100 MG Oral Capsule	SY	ebb177c0-d45d-4443-a85a-e76bd9931a42	11
208675	Dyrenium 50 MG Oral Capsule	SY	ebb177c0-d45d-4443-a85a-e76bd9931a42	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59212-002-01	59212000201	100 CAPSULE in 1 BOTTLE (59212-002-01)	100 capsule	1999-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DYRENIUM ® (triamterene USP) Capsules 50 mg and 100 mg potassium-sparing diuretic	Advanz Pharma (US) Corp.	2024-12-05	Human Prescription Drug Label	11