Home NDC 65162-848 Valsartan and Hydrochlorothiazide
Product NDC 65162-848
11-digit product format 651620848
Labeler code 65162
Product ID 65162-848_e40f4475-c8d3-48a6-913f-cf7c8c7b119b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valsartan and Hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA204382
Marketing category ANDA
Marketing start 2023-08-14
Substance VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength 320; 12.5 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 A204382-001 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;80MG TABLET / ORAL AB 2023-08-11 A204382-002 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;160MG TABLET / ORAL AB 2023-08-11 A204382-003 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;160MG TABLET / ORAL AB 2023-08-11 A204382-004 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 12.5MG;320MG TABLET / ORAL AB 2023-08-11 A204382-005 VALSARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; VALSARTAN 25MG;320MG TABLET / ORAL AB 2023-08-11
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 3 · 110 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 A204382-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204382-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204382-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204382-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204382-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2023-08-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204382-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204382-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204382-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204382-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204382-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2023-08-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204382-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2023-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204382-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2023-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204382-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2023-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204382-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2023-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204382-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2023-08-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204382-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2023-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204382-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2023-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204382-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2023-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204382-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2023-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204382-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2023-08-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204382-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2023-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204382-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2023-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204382-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2023-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204382-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2023-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204382-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2023-08-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204382-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2023-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204382-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2023-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204382-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2023-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204382-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2023-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204382-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2023-08-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204382-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2023-08-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204382-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2023-08-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204382-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2023-08-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204382-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2023-08-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204382-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2023-08-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204382-001 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2023-08-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204382-002 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;160MG TABLET / ORAL AB 2023-08-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204382-003 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;160MG TABLET / ORAL AB 2023-08-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204382-004 VALSARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;320MG TABLET / ORAL AB 2023-08-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204382-005 VALSARTAN AND HYDROCHLOROTHIAZIDE 25MG;320MG TABLET / ORAL AB 2023-08-11 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 110 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 320 mg/1 HYDROCHLOROTHIAZIDE 12.5 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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200284 Internal RxNorm lookup 200285 Internal RxNorm lookup 349353 Internal RxNorm lookup 636042 Internal RxNorm lookup 636045 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 65162-848-03 Valsartan and Hydrochlorothiazide 30 in 1 BOTTLE TABLET, FILM COATED 30 12 65162-848-09 Valsartan and Hydrochlorothiazide 90 in 1 BOTTLE TABLET, FILM COATED 90 12 65162-848-11 Valsartan and Hydrochlorothiazide 1000 in 1 BOTTLE TABLET, FILM COATED 1000 12 65162-848-50 Valsartan and Hydrochlorothiazide 500 in 1 BOTTLE TABLET, FILM COATED 500 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-848 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] 12 Current NDC, 4 package rows 20241031_c9acbc95-3629-4276-842b-5c074844dba7.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 65162-848-03 65162084803 30 TABLET, FILM COATED in 1 BOTTLE (65162-848-03) 2023-08-14 No No Current 65162-848-09 65162084809 90 TABLET, FILM COATED in 1 BOTTLE (65162-848-09) 2023-08-14 No No Current 65162-848-11 65162084811 1000 TABLET, FILM COATED in 1 BOTTLE (65162-848-11) 2023-08-14 No No Current 65162-848-50 65162084850 500 TABLET, FILM COATED in 1 BOTTLE (65162-848-50) 2023-08-14 No No Current