Home NDC 0781-5771 AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE
Product NDC 0781-5771
11-digit product format 007815771
Labeler code 0781
Product ID 0781-5771_07a597a4-a78e-4558-adda-335d316400a2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amlodipine valsartan and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc
Application NDA022314
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2014-12-01
Marketing end 2021-05-31
Substance AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength 5 mg/1; mg/1; mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],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 · 24 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 0781-5771-31 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 0781-5771-31 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0781-5771-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0781-5771-31 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0781-5771-31 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0781-5771-31 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0781-5771-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0781-5771-31 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0781-5771-31 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0781-5771-31 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0781-5771-31 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0781-5771-31 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N022314-001 EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 5MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 N022314-002 EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 5MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 N022314-003 EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 10MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 N022314-004 EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 10MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 N022314-005 EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 10MG BASE;25MG;320MG TABLET / ORAL AB RLD, RS 2009-04-30
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 · 210 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 2026-08-18 06:07:40 2026-07 N022314-001 EXFORGE HCT EQ 5MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022314-002 EXFORGE HCT EQ 5MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022314-003 EXFORGE HCT EQ 10MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022314-004 EXFORGE HCT EQ 10MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022314-005 EXFORGE HCT EQ 10MG BASE;25MG;320MG TABLET / ORAL AB RLD, RS 2009-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022314-001 EXFORGE HCT EQ 5MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022314-002 EXFORGE HCT EQ 5MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022314-003 EXFORGE HCT EQ 10MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022314-004 EXFORGE HCT EQ 10MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022314-005 EXFORGE HCT EQ 10MG BASE;25MG;320MG TABLET / ORAL AB RLD, RS 2009-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022314-001 EXFORGE HCT EQ 5MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022314-002 EXFORGE HCT EQ 5MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022314-003 EXFORGE HCT EQ 10MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022314-004 EXFORGE HCT EQ 10MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022314-005 EXFORGE HCT EQ 10MG BASE;25MG;320MG TABLET / ORAL AB RLD, RS 2009-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022314-001 EXFORGE HCT EQ 5MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022314-002 EXFORGE HCT EQ 5MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022314-003 EXFORGE HCT EQ 10MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022314-004 EXFORGE HCT EQ 10MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022314-005 EXFORGE HCT EQ 10MG BASE;25MG;320MG TABLET / ORAL AB RLD, RS 2009-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022314-001 EXFORGE HCT EQ 5MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022314-002 EXFORGE HCT EQ 5MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022314-003 EXFORGE HCT EQ 10MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022314-004 EXFORGE HCT EQ 10MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022314-005 EXFORGE HCT EQ 10MG BASE;25MG;320MG TABLET / ORAL AB RLD, RS 2009-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022314-001 EXFORGE HCT EQ 5MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022314-002 EXFORGE HCT EQ 5MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022314-003 EXFORGE HCT EQ 10MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022314-004 EXFORGE HCT EQ 10MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022314-005 EXFORGE HCT EQ 10MG BASE;25MG;320MG TABLET / ORAL AB RLD, RS 2009-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022314-001 EXFORGE HCT EQ 5MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022314-002 EXFORGE HCT EQ 5MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022314-003 EXFORGE HCT EQ 10MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022314-004 EXFORGE HCT EQ 10MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022314-005 EXFORGE HCT EQ 10MG BASE;25MG;320MG TABLET / ORAL AB RLD, RS 2009-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022314-001 EXFORGE HCT EQ 5MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022314-002 EXFORGE HCT EQ 5MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022314-003 EXFORGE HCT EQ 10MG BASE;12.5MG;160MG TABLET / ORAL AB RLD 2009-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022314-004 EXFORGE HCT EQ 10MG BASE;25MG;160MG TABLET / ORAL AB RLD 2009-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022314-005 EXFORGE HCT EQ 10MG BASE;25MG;320MG TABLET / ORAL AB RLD, RS 2009-04-30 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 210 observed states.
Observed Orange Book patent history# Patent history page 1 of 9 · 360 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-001 8101599 2023-05-16 Drug product 2012-01-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-001 8475839 2023-05-16 Drug product 2013-08-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-001 8475839*PED 2023-11-16 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-002 8101599 2023-05-16 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-002 8475839 2023-05-16 Drug product 2013-08-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-002 8475839*PED 2023-11-16 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-003 8101599 2023-05-16 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-003 8475839 2023-05-16 Drug product 2013-08-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-003 8475839*PED 2023-11-16 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-004 8101599 2023-05-16 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-004 8475839 2023-05-16 Drug product 2013-08-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-004 8475839*PED 2023-11-16 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-005 8101599 2023-05-16 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-005 8475839 2023-05-16 Drug product 2013-08-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022314-005 8475839*PED 2023-11-16 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022314-001 8101599 2023-05-16 Drug product 2012-01-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-001 8475839 2023-05-16 Drug product 2013-08-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-001 8475839*PED 2023-11-16 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-002 8101599 2023-05-16 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-002 8475839 2023-05-16 Drug product 2013-08-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-002 8475839*PED 2023-11-16 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-003 8101599 2023-05-16 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-003 8475839 2023-05-16 Drug product 2013-08-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-003 8475839*PED 2023-11-16 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-004 8101599 2023-05-16 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-004 8475839 2023-05-16 Drug product 2013-08-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-004 8475839*PED 2023-11-16 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-005 8101599 2023-05-16 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-005 8475839 2023-05-16 Drug product 2013-08-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022314-005 8475839*PED 2023-11-16 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022314-001 8101599 2023-05-16 Drug product 2012-01-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022314-001 8475839 2023-05-16 Drug product 2013-08-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022314-001 8475839*PED 2023-11-16 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022314-002 8101599 2023-05-16 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022314-002 8475839 2023-05-16 Drug product 2013-08-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022314-002 8475839*PED 2023-11-16 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022314-003 8101599 2023-05-16 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022314-003 8475839 2023-05-16 Drug product 2013-08-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022314-003 8475839*PED 2023-11-16 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022314-004 8101599 2023-05-16 Drug product 4b0b4de00fa7…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMLODIPINE BESYLATE ACTIVE INGREDIENT 864V2Q084H AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANDOZ INC] 1 HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANDOZ INC] 1 VALSARTAN ACTIVE INGREDIENT 80M03YXJ7I AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANDOZ INC] 1 AMLODIPINE ACTIVE MOIETY 1J444QC288 AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANDOZ INC] 1 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANDOZ INC] 1 VALSARTAN ACTIVE MOIETY 80M03YXJ7I AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANDOZ INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANDOZ INC] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANDOZ INC] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANDOZ INC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANDOZ INC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANDOZ INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANDOZ INC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANDOZ INC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANDOZ INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [SANDOZ INC] 1
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Exforge HCT AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE Novartis Pharmaceuticals Corporation 18d7820d-471f-4ee2-9ec6-25d8d27c77de 2025-12-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022314 application number: NDA022314