Triamterene and Hydrochlorothiazide

Product NDC
63629-6404
Requested package NDC
63629-6404-1
11-digit product format
636296404
Labeler code
63629
Product ID
63629-6404_f20127b7-9a3a-46ed-b64e-a8ae880ae9ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamterene and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA019129
Marketing category
NDA
Marketing start
1996-09-16
Marketing end
0000-00-00
Substance
TRIAMTERENE; HYDROCHLOROTHIAZIDE
Active strength
75 mg/1; mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-640463629-6404-1DDiscontinued by firm2026-10-05

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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019129-001MAXZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENE50MG;75MGTABLET / ORALABRLD, RS1984-10-22
N019129-003MAXZIDE-25HYDROCHLOROTHIAZIDE; TRIAMTERENE25MG;37.5MGTABLET / ORALABRLD1988-05-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N019129-001AB
N019129-003AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-2284e616aacf4f…
2026-09-14 22:38:342026-08N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-1384e616aacf4f…
2026-08-18 06:07:402026-07N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019129-001MAXZIDE50MG;75MGTABLET / ORALABRLD, RS1984-10-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019129-003MAXZIDE-2525MG;37.5MGTABLET / ORALABRLD1988-05-1374a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N019129-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N019129-003AB184e616aacf4f…
2026-08-18 06:07:402026-07N019129-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N019129-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019129-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019129-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019129-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019129-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019129-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019129-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019129-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019129-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019129-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019129-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019129-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019129-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019129-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019129-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019129-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019129-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019129-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019129-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019129-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019129-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019129-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019129-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019129-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019129-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019129-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019129-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019129-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019129-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019129-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019129-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019129-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019129-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019129-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019129-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019129-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019129-003AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-6404-12020-10-16C16284748780-19d75b9d0-ae76-f424-e053-dadaa90a57ce8ae12746-d16d-4743-ac3e-d1e010eeb638
63629-6404-12020-01-31C16284748780-19d75b9d0-ae76-f424-e053-dadaa90a57ce8ae12746-d16d-4743-ac3e-d1e010eeb638

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-6404-16362964040130 TABLET in 1 BOTTLE (63629-6404-1) 30 tablet2015-09-170000-00-00NoNoCurrent