Home NDC 0378-1352-05 Triamterene and Hydrochlorothiazide
Product NDC 0378-1352
Requested package NDC 0378-1352-05
11-digit product format 003781352
Labeler code 0378
Product ID 0378-1352_ca543400-41df-41cc-8eef-adc5d7d724f1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Triamterene and Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA019129
Marketing category NDA
Marketing start 1996-09-16
Marketing end 2022-07-31
Substance HYDROCHLOROTHIAZIDE; TRIAMTERENE
Active strength 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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019129-001 MAXZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 N019129-003 MAXZIDE-25 HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 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 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019129-001 MAXZIDE 50MG;75MG TABLET / ORAL AB RLD, RS 1984-10-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019129-003 MAXZIDE-25 25MG;37.5MG TABLET / ORAL AB RLD 1988-05-13 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.] 4 TRIAMTERENE ACTIVE INGREDIENT WS821Z52LQ TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.] 4 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.] 4 TRIAMTERENE ACTIVE MOIETY WS821Z52LQ TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.] 4 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.] 4 HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TRIAMTERENE ACTIVE INGREDIENT WS821Z52LQ TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TRIAMTERENE ACTIVE INGREDIENT WS821Z52LQ TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 TRIAMTERENE ACTIVE MOIETY WS821Z52LQ TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 TRIAMTERENE ACTIVE MOIETY WS821Z52LQ TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 2 HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 TRIAMTERENE ACTIVE INGREDIENT WS821Z52LQ TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 TRIAMTERENE ACTIVE MOIETY WS821Z52LQ TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BLENHEIM PHARMACAL, INC.] 1
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 0378-1352-05 00378135205 500 TABLET in 1 BOTTLE, PLASTIC (0378-1352-05) 500 tablet 1996-09-16 2022-07-31 No No Current