Home NDC 0591-2318 Valsartan and Hydrochlorothiazide
Product NDC 0591-2318
11-digit product format 005912318
Labeler code 0591
Product ID 0591-2318_c82aa03f-f5d4-43ec-a7a8-96a1c3de644a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valsartan and Hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA091519
Marketing category ANDA
Marketing start 2013-03-21
Marketing end 2019-08-31
Substance VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength 320 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 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 · 26 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0591-2318-19 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0591-2318-19 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0591-2318-19 D Discontinued by firm excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0591-2318-19 D Discontinued by firm excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0591-2318-19 D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0591-2318-19 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0591-2318-19 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0591-2318-19 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0591-2318-19 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0591-2318-19 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0591-2318-19 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0591-2318-19 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2019-06-01 22:24 UTC · source 2019-05-30 unfinished product product UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 5b2001dcd8f5…54b53d4dc9e4…2019-06-01 22:24 UTC · source 2019-05-30 unfinished package package 0591-2318-00 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 5b2001dcd8f5…54b53d4dc9e4…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A091519-001 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET / ORAL 2013-03-21 A091519-002 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET / ORAL 2013-03-21 A091519-003 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET / ORAL 2013-03-21 A091519-004 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET / ORAL 2013-03-21 A091519-005 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET / ORAL 2013-03-21
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 · 215 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 A091519-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2013-03-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091519-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2013-03-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091519-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2013-03-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091519-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2013-03-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091519-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2013-03-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091519-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2013-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091519-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2013-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091519-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2013-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091519-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2013-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091519-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2013-03-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091519-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2013-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091519-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2013-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091519-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2013-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091519-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2013-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091519-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2013-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091519-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2013-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091519-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2013-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091519-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2013-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091519-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2013-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091519-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2013-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091519-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2013-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091519-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2013-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091519-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2013-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091519-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2013-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091519-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2013-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091519-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2013-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091519-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2013-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091519-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2013-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091519-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2013-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091519-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2013-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091519-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2013-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091519-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2013-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091519-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2013-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091519-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2013-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091519-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2013-03-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091519-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2013-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091519-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2013-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091519-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2013-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091519-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2013-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091519-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2013-03-21 03ed91905a0d…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE, INC.] 1 VALSARTAN ACTIVE INGREDIENT 80M03YXJ7I VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE, INC.] 1 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE, INC.] 1 VALSARTAN ACTIVE MOIETY 80M03YXJ7I VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE, INC.] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE, INC.] 1 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE, INC.] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE, INC.] 1