Home NDC 63629-8732-1 Triamterene and Hydrochlorothiazide
Product NDC 63629-8732
Requested package NDC 63629-8732-1
11-digit product format 636298732
Labeler code 63629
Product ID 63629-8732_c53c8fb1-e251-4138-9277-8d28a8e8bcc9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Triamterene and Hydrochlorothiazide
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA074821
Marketing category ANDA
Marketing start 1997-06-05
Substance TRIAMTERENE; HYDROCHLOROTHIAZIDE
Active strength 37.5; 25 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 · 45 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 2026-11-14 07:37:17 2026-10 A074821-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB RS 1997-06-05 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A074821-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;37.5MG CAPSULE / ORAL AB RS 1997-06-05 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 45 observed states.
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 Triamterene and Hydrochlorothiazide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIAMTERENE 37.5 mg/1 HYDROCHLOROTHIAZIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WS821Z52LQ Internal UNII lookup 0J48LPH2TH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198316 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-8732-1 Triamterene and Hydrochlorothiazide 100 in 1 BOTTLE CAPSULE 100 105
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-8732 TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK] 105 Current NDC, Legacy NDC, 1 package rows 20241027_24d40f18-b98c-48fc-8d97-5f3e351afc31.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 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 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-8732-1 63629873201 100 CAPSULE in 1 BOTTLE (63629-8732-1) 100 capsule 1997-06-05 0000-00-00 No No Current