Triamterene and Hydrochlorothiazide

Product NDC: 45865-402
Requested package NDC: 45865-402-60
11-digit product format: 458650402
Labeler code: 45865
Product ID: 45865-402_9ab200ad-fc48-aa27-e053-2995a90ab079
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Triamterene and Hydrochlorothiazide
Dosage form: CAPSULE
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA074821
Marketing category: ANDA
Marketing start: 1997-06-05
Marketing end: 0000-00-00
Substance: TRIAMTERENE; HYDROCHLOROTHIAZIDE
Active strength: 38 mg/1; mg/1
Pharmacologic classes: Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	45865-402	45865-402-60	I	Inactivated by FDA		2026-10-05

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TRIAMTERENE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074821-001	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 2 · 43 observed 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
2026-09-14 22:38:34	2026-08	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB		1997-06-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB		1997-06-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB		1997-06-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB		1997-06-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB		1997-06-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB		1997-06-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074821-001	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	25MG;37.5MG	CAPSULE / ORAL	AB	RS	1997-06-05	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A074821-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074821-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074821-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074821-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074821-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074821-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074821-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074821-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074821-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074821-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074821-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074821-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074821-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074821-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074821-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074821-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074821-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074821-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074821-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074821-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074821-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074821-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074821-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074821-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074821-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074821-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074821-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074821-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074821-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074821-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074821-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074821-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074821-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074821-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074821-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074821-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074821-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074821-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074821-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074821-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
1199f4b7-b537-466c-9a1c-cb09131e9f8b	Product name	1	20251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
b2ea36e8-564d-01b9-8552-a327d058eb0f	Product name	2	20200203
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612
c27b049d-3258-48cf-ebe5-08c236ae78e2	Product name	3	20190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
ea069444-e874-4c28-833f-d2f52734ef4d	Product name	1	20150206
041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
433a3439-b8f3-d13a-d2c8-9b221d628d60	Product name	1	20140508
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-402-60	2025-01-30	C162847	48780-1	2cef2736-62f1-d83d-e063-dadaa90ab31f	Triamterene and Hydrochlorothiazide Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-402-60	Triamterene and Hydrochlorothiazide	60 in 1 BOTTLE	CAPSULE	60		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
TRIAMTERENE	ACTIVE INGREDIENT	WS821Z52LQ	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
TRIAMTERENE	ACTIVE MOIETY	WS821Z52LQ	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-402	TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MEDSOURCE PHARMACEUTICALS]	2	Legacy NDC, 1 package rows	20191228_1d631948-6491-7270-e054-00144ff88e88.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Sandoz Inc	f824b6ba-bd1c-41a8-8f6f-ad507b48f3e0	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074821 application number: ANDA074821
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	db895e64-3f97-9201-e053-2a95a90ac7ef	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074821 application number: ANDA074821
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals, Inc.	3b3c92b1-bec3-2768-e063-6394a90a9af8	2025-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074821 application number: ANDA074821
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	24d40f18-b98c-48fc-8d97-5f3e351afc31	2024-10-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074821 application number: ANDA074821
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	d3dce0c7-9e5f-49f8-bcc2-1919a30565fd	2024-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074821 application number: ANDA074821
Triamterene and Hydrochlorothiazide	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	f11598d2-87ee-4292-8631-c29c54f4dfa9	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074821 application number: ANDA074821

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WS821Z52LQ	TRIAMTERENE	396-01-0	TRIAMTERENE
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198316	hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral Capsule	PSN	1d631948-6491-7270-e054-00144ff88e88	2
198316	hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Capsule	SCD	1d631948-6491-7270-e054-00144ff88e88	2
198316	HCTZ 25 MG / triamterene 37.5 MG Oral Capsule	SY	1d631948-6491-7270-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-402-60	45865040260	60 CAPSULE in 1 BOTTLE (45865-402-60)	60 capsule	2015-08-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Triamterene and Hydrochlorothiazide Capsules, USP	Medsource Pharmaceuticals	2019-12-27	HUMAN PRESCRIPTION DRUG LABEL	2