Home NDC 55289-838 Diovan HCT
Product NDC 55289-838
11-digit product format 552890838
Labeler code 55289
Product ID 55289-838_e238472f-03a8-b904-e053-2995a90aec5c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valsartan and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA020818
Marketing category NDA
Marketing start 1998-03-06
Marketing end 0000-00-00
Substance HYDROCHLOROTHIAZIDE; VALSARTAN
Active strength 13 mg/1; mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55289-838-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55289-838-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55289-838-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55289-838-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55289-838-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55289-838-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55289-838-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55289-838-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55289-838-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55289-838-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55289-838-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55289-838-30 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020818-001 DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET / ORAL AB RLD 1998-03-06 N020818-002 DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET / ORAL AB RLD 1998-03-06 N020818-003 DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET / ORAL AB RLD 2002-01-17 N020818-004 DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET / ORAL AB RLD 2006-04-28 N020818-005 DIOVAN HCT HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET / ORAL AB RLD, RS 2006-04-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 6 · 205 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 2026-02-19 14:30 UTC 2026-02 N020818-001 DIOVAN HCT 12.5MG;80MG TABLET / ORAL AB RLD 1998-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020818-002 DIOVAN HCT 12.5MG;160MG TABLET / ORAL AB RLD 1998-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020818-003 DIOVAN HCT 25MG;160MG TABLET / ORAL AB RLD 2002-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020818-004 DIOVAN HCT 12.5MG;320MG TABLET / ORAL AB RLD 2006-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020818-005 DIOVAN HCT 25MG;320MG TABLET / ORAL AB RLD, RS 2006-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020818-001 DIOVAN HCT 12.5MG;80MG TABLET / ORAL AB RLD 1998-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020818-002 DIOVAN HCT 12.5MG;160MG TABLET / ORAL AB RLD 1998-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020818-003 DIOVAN HCT 25MG;160MG TABLET / ORAL AB RLD 2002-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020818-004 DIOVAN HCT 12.5MG;320MG TABLET / ORAL AB RLD 2006-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020818-005 DIOVAN HCT 25MG;320MG TABLET / ORAL AB RLD, RS 2006-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020818-001 DIOVAN HCT 12.5MG;80MG TABLET / ORAL AB RLD 1998-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020818-002 DIOVAN HCT 12.5MG;160MG TABLET / ORAL AB RLD 1998-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020818-003 DIOVAN HCT 25MG;160MG TABLET / ORAL AB RLD 2002-01-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020818-004 DIOVAN HCT 12.5MG;320MG TABLET / ORAL AB RLD 2006-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020818-005 DIOVAN HCT 25MG;320MG TABLET / ORAL AB RLD, RS 2006-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020818-001 DIOVAN HCT 12.5MG;80MG TABLET / ORAL AB RLD 1998-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020818-002 DIOVAN HCT 12.5MG;160MG TABLET / ORAL AB RLD 1998-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020818-003 DIOVAN HCT 25MG;160MG TABLET / ORAL AB RLD 2002-01-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020818-004 DIOVAN HCT 12.5MG;320MG TABLET / ORAL AB RLD 2006-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020818-005 DIOVAN HCT 25MG;320MG TABLET / ORAL AB RLD, RS 2006-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020818-001 DIOVAN HCT 12.5MG;80MG TABLET / ORAL AB RLD 1998-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020818-002 DIOVAN HCT 12.5MG;160MG TABLET / ORAL AB RLD 1998-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020818-003 DIOVAN HCT 25MG;160MG TABLET / ORAL AB RLD 2002-01-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020818-004 DIOVAN HCT 12.5MG;320MG TABLET / ORAL AB RLD 2006-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020818-005 DIOVAN HCT 25MG;320MG TABLET / ORAL AB RLD, RS 2006-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020818-001 DIOVAN HCT 12.5MG;80MG TABLET / ORAL AB RLD 1998-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020818-002 DIOVAN HCT 12.5MG;160MG TABLET / ORAL AB RLD 1998-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020818-003 DIOVAN HCT 25MG;160MG TABLET / ORAL AB RLD 2002-01-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020818-004 DIOVAN HCT 12.5MG;320MG TABLET / ORAL AB RLD 2006-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020818-005 DIOVAN HCT 25MG;320MG TABLET / ORAL AB RLD, RS 2006-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020818-001 DIOVAN HCT 12.5MG;80MG TABLET / ORAL AB RLD 1998-03-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020818-002 DIOVAN HCT 12.5MG;160MG TABLET / ORAL AB RLD 1998-03-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020818-003 DIOVAN HCT 25MG;160MG TABLET / ORAL AB RLD 2002-01-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020818-004 DIOVAN HCT 12.5MG;320MG TABLET / ORAL AB RLD 2006-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020818-005 DIOVAN HCT 25MG;320MG TABLET / ORAL AB RLD, RS 2006-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020818-001 DIOVAN HCT 12.5MG;80MG TABLET / ORAL AB RLD 1998-03-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020818-002 DIOVAN HCT 12.5MG;160MG TABLET / ORAL AB RLD 1998-03-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020818-003 DIOVAN HCT 25MG;160MG TABLET / ORAL AB RLD 2002-01-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020818-004 DIOVAN HCT 12.5MG;320MG TABLET / ORAL AB RLD 2006-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020818-005 DIOVAN HCT 25MG;320MG TABLET / ORAL AB RLD, RS 2006-04-28 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 205 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 VALSARTAN ACTIVE INGREDIENT 80M03YXJ7I DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 VALSARTAN ACTIVE MOIETY 80M03YXJ7I DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 TALC INACTIVE INGREDIENT 7SEV7J4R1U DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 11
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diovan HCT VALSARTAN AND HYDROCHLOROTHIAZIDE Novartis Pharmaceuticals Corporation d76a0419-05ee-437e-884c-65807aea9569 2026-02-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020818 application number: NDA020818
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55289-838-30 55289083830 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-838-30) 2012-02-22 0000-00-00 No No Current