Home NDC 63187-428 Valsartan and hydrochlorothiazide
Product NDC 63187-428
11-digit product format 631870428
Labeler code 63187
Product ID 63187-428_3aa14bc0-eb0c-4860-abd0-4bd3203e5ec0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valsartan and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA091519
Marketing category ANDA
Marketing start 2013-03-21
Marketing end 0000-00-00
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 2020-12-31
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 · 6 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 63187-428-30 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63187-428-90 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 63187-428-30 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63187-428-90 f5e01cc5f278…a2eaf40c39c3…
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 TABLET, FILM COATED [PROFICIENT RX LP] 2 VALSARTAN ACTIVE INGREDIENT 80M03YXJ7I VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP] 2 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP] 2 VALSARTAN ACTIVE MOIETY 80M03YXJ7I VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP] 2 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-428 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP] 4 Legacy NDC 20191121_bfbc596d-e39d-4413-93e5-f5133705db38.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63187-428-30 63187042830 30 TABLET, FILM COATED in 1 BOTTLE (63187-428-30) 2014-03-03 0000-00-00 No No Current 63187-428-90 63187042890 90 TABLET, FILM COATED in 1 BOTTLE (63187-428-90) 2014-03-03 0000-00-00 No No Current