Home NDC 71205-249 Valsartan and Hydrochlorothiazide
Product NDC 71205-249
11-digit product format 712050249
Labeler code 71205
Product ID 71205-249_3129e59a-5814-4050-bd80-29f469ca66a2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valsartan and Hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA078946
Marketing category ANDA
Marketing start 2013-03-21
Substance HYDROCHLOROTHIAZIDE; VALSARTAN
Active strength 12.5; 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 2027-12-31
Current FDA listing Yes 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 A078946-001 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET / ORAL 2013-03-21 A078946-002 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET / ORAL 2013-03-21 A078946-003 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET / ORAL 2013-03-21 A078946-004 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET / ORAL 2013-03-21 A078946-005 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG 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 A078946-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2013-03-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078946-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2013-03-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078946-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2013-03-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078946-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2013-03-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078946-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2013-03-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078946-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL 2013-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078946-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL 2013-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078946-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL 2013-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078946-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL 2013-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078946-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL 2013-03-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078946-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2013-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078946-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2013-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078946-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2013-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078946-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2013-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078946-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2013-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078946-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2013-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078946-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2013-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078946-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2013-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078946-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2013-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078946-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2013-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078946-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2013-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078946-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2013-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078946-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2013-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078946-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2013-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078946-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2013-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078946-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2013-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078946-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2013-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078946-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2013-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078946-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2013-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078946-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2013-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078946-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2013-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078946-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2013-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078946-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2013-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078946-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2013-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078946-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2013-03-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078946-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2013-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078946-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2013-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078946-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2013-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078946-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2013-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078946-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2013-03-21 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 200 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Valsartan and Hydrochlorothiazide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCHLOROTHIAZIDE 12.5 mg/1 VALSARTAN 80 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0J48LPH2TH Internal UNII lookup 80M03YXJ7I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200284 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71205-249-30 Valsartan and Hydrochlorothiazide 30 in 1 BOTTLE TABLET, FILM COATED 30 2 71205-249-60 Valsartan and Hydrochlorothiazide 60 in 1 BOTTLE TABLET, FILM COATED 60 2 71205-249-90 Valsartan and Hydrochlorothiazide 90 in 1 BOTTLE TABLET, FILM COATED 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-249 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PROFICIENT RX LP] 2 Current NDC, Legacy NDC, 3 package rows 20191010_be008c6a-6036-4abf-a3fc-450465c88d55.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71205-249-30 71205024930 30 TABLET, FILM COATED in 1 BOTTLE (71205-249-30) 2019-04-01 0000-00-00 No No Current 71205-249-60 71205024960 60 TABLET, FILM COATED in 1 BOTTLE (71205-249-60) 2019-04-01 0000-00-00 No No Current 71205-249-90 71205024990 90 TABLET, FILM COATED in 1 BOTTLE (71205-249-90) 2019-04-01 0000-00-00 No No Current