Home NDC 68258-6095 Valsartan and Hydrochlorothiazide
Product NDC 68258-6095
11-digit product format 682586095
Labeler code 68258
Product ID 68258-6095_c2f46e16-af36-41ea-a860-47f23b9612b4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valsartan and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dispensing Solutions, Inc.
Application NDA020818
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2012-09-21
Marketing end 0000-00-00
Substance VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength 160 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 E
Listing certified through 2017-12-31
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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68258-6095-3 Valsartan and Hydrochlorothiazide 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 2 68258-6095-9 Valsartan and Hydrochlorothiazide 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 VALSARTAN ACTIVE INGREDIENT 80M03YXJ7I VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 VALSARTAN ACTIVE MOIETY 80M03YXJ7I VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68258-6095 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] 2 Legacy NDC, 2 package rows 20131107_b8f076d5-f271-4099-8d86-c7b02beece08.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 · 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 68258-6095-3 68258609503 30 in 1 BOTTLE, PLASTIC Historical 68258-6095-9 68258609509 90 in 1 BOTTLE, PLASTIC Historical