Triamterene and Hydrochlorothiazide

Product NDC
63187-905
11-digit product format
631870905
Labeler code
63187
Product ID
63187-905_bfe1a860-0657-4f48-9b82-31f9483838c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamterene and Hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA201407
Marketing category
ANDA
Marketing start
2011-12-12
Substance
HYDROCHLOROTHIAZIDE; TRIAMTERENE
Active strength
25; 37.5 mg/1; mg/1
Pharmacologic classes
Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENE25MG;37.5MGCAPSULE / ORALAB2011-12-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201407-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-093f01610625f2…
2019-09-15 20:21 UTC2019-09A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201407-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB2011-12-09cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201407-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201407-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201407-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201407-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201407-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201407-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201407-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201407-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201407-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201407-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201407-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201407-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201407-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201407-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201407-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201407-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201407-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201407-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201407-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201407-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201407-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A201407-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201407-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201407-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201407-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A201407-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201407-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201407-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201407-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201407-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201407-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201407-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201407-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201407-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A201407-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A201407-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201407-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201407-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201407-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201407-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Triamterene and Hydrochlorothiazide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMTERENE25 mg/1
HYDROCHLOROTHIAZIDE37.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WS821Z52LQInternal UNII lookup
0J48LPH2THInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198316Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
189ad040-07e9-42a5-854c-67633367da74Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
b2ea36e8-564d-01b9-8552-a327d058eb0fProduct name220200203
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-905-30Triamterene and Hydrochlorothiazide30 in 1 BOTTLECAPSULE305
63187-905-60Triamterene and Hydrochlorothiazide60 in 1 BOTTLECAPSULE605
63187-905-90Triamterene and Hydrochlorothiazide90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-905-30EA - Each63187-905e846d7f0-433c-43a8-b7d5-b9f15345a5c812018-02-20
63187-905-90EA - Each63187-9053c594c8b-14e4-49a0-b70b-a3c293855ef012017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-905TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20230115_189ad040-07e9-42a5-854c-67633367da74.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIAMTERENE AND HYDROCHLOROTHIAZIDETRIAMTERENE AND HYDROCHLOROTHIAZIDEChartwell RX, LLC261dd83f-8048-488f-8b71-c4abd96927202025-12-10Adverse reactionsExact identifier
application applno (ANDA): 201407
application number: ANDA201407
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsd692b189-1b06-46f5-a257-758a7dede8632024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201407
application number: ANDA201407
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack6517777a-e49e-4da6-b34b-66ec58cceff72024-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201407
application number: ANDA201407
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack8cc154c2-2ed2-4d7c-95a5-e2946393270c2023-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201407
application number: ANDA201407
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEProficient Rx LP189ad040-07e9-42a5-854c-67633367da742023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201407
application number: ANDA201407
ndc (product): 63187-905

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198316hydroCHLOROthiazide 25 MG / triamterene 37.5 MG Oral CapsulePSN189ad040-07e9-42a5-854c-67633367da745
198316hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral CapsuleSCD189ad040-07e9-42a5-854c-67633367da745
198316HCTZ 25 MG / triamterene 37.5 MG Oral CapsuleSY189ad040-07e9-42a5-854c-67633367da745

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-905-306318709053030 CAPSULE in 1 BOTTLE (63187-905-30) 30 capsule2017-09-010000-00-00NoNoCurrent
63187-905-606318709056060 CAPSULE in 1 BOTTLE (63187-905-60) 60 capsule2017-09-010000-00-00NoNoCurrent
63187-905-906318709059090 CAPSULE in 1 BOTTLE (63187-905-90) 90 capsule2017-09-010000-00-00NoNoCurrent