Home NDC 50090-5985 Valsartan and Hydrochlorothiazide
Product NDC 50090-5985
11-digit product format 500905985
Labeler code 50090
Product ID 50090-5985_67e8d1ee-ea2c-48ad-911f-696692652d2e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valsartan and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA078020
Marketing category ANDA
Marketing start 2012-09-21
Substance VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength 160; 25 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 2026-12-31
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 A078020-001 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET / ORAL AB 2012-09-21 A078020-002 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET / ORAL AB 2012-09-21 A078020-003 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET / ORAL AB 2012-09-21 A078020-004 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET / ORAL AB 2012-09-21 A078020-005 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET / ORAL AB 2012-09-21
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 · 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 A078020-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2012-09-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078020-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2012-09-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078020-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2012-09-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078020-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2012-09-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078020-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2012-09-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078020-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2012-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078020-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2012-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078020-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2012-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078020-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2012-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078020-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2012-09-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078020-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2012-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078020-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2012-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078020-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2012-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078020-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2012-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078020-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2012-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078020-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2012-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078020-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2012-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078020-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2012-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078020-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2012-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078020-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2012-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078020-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2012-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078020-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2012-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078020-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2012-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078020-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2012-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078020-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2012-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078020-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2012-09-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078020-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2012-09-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078020-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2012-09-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078020-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2012-09-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078020-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2012-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078020-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2012-09-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078020-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2012-09-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078020-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2012-09-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078020-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2012-09-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078020-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2012-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078020-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2012-09-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078020-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2012-09-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078020-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2012-09-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078020-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2012-09-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078020-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2012-09-21 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 215 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALSARTAN 160 mg/1 HYDROCHLOROTHIAZIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 80M03YXJ7I Internal UNII lookup 0J48LPH2TH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349353 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 50090-5985-0 Valsartan and Hydrochlorothiazide 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5985 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 3 Current NDC, Legacy NDC, 1 package rows 20230510_1b72ecfd-a08d-48c5-a853-d3bc9ff882f1.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Valsartan and Hydrochlorothiazide VALSARTAN AND HYDROCHLOROTHIAZIDE Northwind Health Company, LLC f2b749a6-17ff-e044-e053-2995a90aea28 2026-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078020 application number: ANDA078020 Valsartan and Hydrochlorothiazide VALSARTAN AND HYDROCHLOROTHIAZIDE Northwind Health Company, LLC f835fa93-6529-c06d-e053-6394a90ad42a 2026-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078020 application number: ANDA078020 Valsartan and Hydrochlorothiazide VALSARTAN AND HYDROCHLOROTHIAZIDE A-S Medication Solutions 1b72ecfd-a08d-48c5-a853-d3bc9ff882f1 2023-05-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078020 application number: ANDA078020 ndc (product): 50090-5985 Valsartan and Hydrochlorothiazide VALSARTAN AND HYDROCHLOROTHIAZIDE Mylan Pharmaceuticals Inc. 3ba1f9f9-0037-4522-8605-e27dc8552b5b 2023-04-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078020 application number: ANDA078020
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 50090-5985-0 50090598500 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-5985-0) 2022-05-27 0000-00-00 No No Current