Home NDC 68382-279 valsartan and hydrochlorothiazide
Product NDC 68382-279
11-digit product format 683820279
Labeler code 68382
Product ID 68382-279_84d7e724-d8f9-4ced-9013-b064226d482d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valsartan and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals (USA) Inc.
Application ANDA203000
Marketing category ANDA
Marketing start 2020-02-12
Marketing end 0000-00-00
Substance VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength 80 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 2021-12-31
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 · 48 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 A203000-001 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET / ORAL 2019-03-15 A203000-002 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET / ORAL 2019-03-15 A203000-003 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET / ORAL 2019-03-15 A203000-004 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET / ORAL 2019-03-15 A203000-005 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET / ORAL 2019-03-15
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 A203000-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2019-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203000-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2019-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203000-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2019-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203000-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2019-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203000-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2019-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203000-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2019-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203000-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2019-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203000-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2019-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203000-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2019-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203000-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2019-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203000-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2019-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203000-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2019-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203000-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2019-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203000-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2019-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203000-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2019-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203000-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2019-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203000-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2019-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203000-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2019-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203000-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2019-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203000-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2019-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203000-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2019-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203000-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2019-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203000-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2019-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203000-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2019-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203000-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2019-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203000-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2019-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203000-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2019-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203000-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2019-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203000-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2019-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203000-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2019-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203000-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2019-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203000-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2019-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203000-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2019-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203000-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2019-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203000-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2019-03-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203000-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2019-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203000-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2019-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203000-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2019-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203000-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2019-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203000-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2019-03-15 5bbf6a4d5a75…
Observed Orange Book normalized TE history# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68382-279-10 68382027910 1000 TABLET, FILM COATED in 1 BOTTLE (68382-279-10) 2020-02-12 0000-00-00 No No Current 68382-279-16 68382027916 90 TABLET, FILM COATED in 1 BOTTLE (68382-279-16) 2020-02-12 0000-00-00 No No Current 68382-279-77 68382027977 10 BLISTER PACK in 1 CARTON (68382-279-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-279-30) 10 blister pack 2020-02-12 0000-00-00 No No Current