Exforge HCT

Product NDC: 0078-0562
11-digit product format: 000780562
Labeler code: 0078
Product ID: 0078-0562_e10fea42-c6e7-4584-9a0a-0709c5323cd8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amlodipine valsartan and hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA022314
Marketing category: NDA
Marketing start: 2009-04-04
Substance: AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength: 10; 160; 25 mg/1; mg/1; mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0078-0562	0078-0562-30	D	Discontinued by firm		2026-10-05

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
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.

Application-product, TE code table
Application-product	TE code
N022314-001	AB
N022314-002	AB
N022314-003	AB
N022314-004	AB
N022314-005	AB

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	N022314-001	EXFORGE HCT	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022314-002	EXFORGE HCT	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022314-003	EXFORGE HCT	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022314-004	EXFORGE HCT	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022314-005	EXFORGE HCT	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	RLD, RS	2009-04-30	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N022314-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022314-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022314-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022314-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022314-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022314-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022314-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022314-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022314-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022314-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022314-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022314-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022314-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022314-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022314-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022314-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022314-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022314-005	AB	1	`03ed91905a0d…`

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	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…`

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: Exforge HCT
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMLODIPINE BESYLATE	10 mg/1
VALSARTAN	160 mg/1
HYDROCHLOROTHIAZIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
864V2Q084H	Internal UNII lookup
80M03YXJ7I	Internal UNII lookup
0J48LPH2TH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
848131	Internal RxNorm lookup
848134	Internal RxNorm lookup
848135	Internal RxNorm lookup
848139	Internal RxNorm lookup
848140	Internal RxNorm lookup
848144	Internal RxNorm lookup
848145	Internal RxNorm lookup
848149	Internal RxNorm lookup
848151	Internal RxNorm lookup
848155	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
18d7820d-471f-4ee2-9ec6-25d8d27c77de	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
692a3434-fece-49c6-9b7d-ed7aefc52b50	Product name	3	20260317
fa898d56-9495-d6f0-309b-68a5d8e3914a	Product name	4	20260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
1199f4b7-b537-466c-9a1c-cb09131e9f8b	Product name	1	20251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
265792b3-b999-c010-7364-a7db20b9d4d9	Product name	5	20250515
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
e7dfdaab-7cf9-4f89-804c-eff5108d94d1	Product name	9	20250305
b6abae2f-ee27-47bc-b150-54dc8d969483	Product name	2	20250221
52311e76-a520-4bd2-9d5b-e0b6d6f44519	Product name	2	20231208
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
14c2c15b-f823-4ada-a40e-a440544294dc	Product name	1	20221207
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
a72887ef-d675-499f-af4b-78688f6855cd	Product name	1	20191002
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612
c27b049d-3258-48cf-ebe5-08c236ae78e2	Product name	3	20190610
a4484670-2869-6416-f6ff-03b1b3cbd1b0	Product name	2	20190415
4a27501f-a987-48a5-99b4-e983d4744d76	Product name	7	20181211
18600d07-613d-bf9c-2711-fe40c06f3393	Product name	5	20180703
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
bded1554-44de-900a-5297-403365d6d4b2	Product name	3	20170110
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1	Product name	1	20150316
ea069444-e874-4c28-833f-d2f52734ef4d	Product name	1	20150206
041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
433a3439-b8f3-d13a-d2c8-9b221d628d60	Product name	1	20140508
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508
63ab5fbf-2a6b-c41d-051a-39e845d718b1	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508
f5231d08-c52b-a5a0-ba93-675895c292be	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0078-0562-15	Exforge HCT	30 in 1 BOTTLE	TABLET, FILM COATED	30	33
0078-0562-30	Exforge HCT	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	33
0078-0562-30	Exforge HCT	30 in 1 CARTON	TABLET, FILM COATED	30	33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0562-15	EA - Each	0078-0562	9d068f15-1a5a-45b9-97ae-8046a0052902	1	2012-07-24
0078-0562-30	EA - Each	0078-0562	51f317e9-4041-4588-93ee-d4ef5779f874	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	15
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	15
VALSARTAN	ACTIVE INGREDIENT	80M03YXJ7I	EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	15
AMLODIPINE	ACTIVE MOIETY	1J444QC288	EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	15
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	15
VALSARTAN	ACTIVE MOIETY	80M03YXJ7I	EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	15
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	15
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	15
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	15
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	15
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0562	EXFORGE HCT (AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	32	Current NDC, Legacy NDC, 3 package rows	20250110_18d7820d-471f-4ee2-9ec6-25d8d27c77de.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 · 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 ndc (product): 0078-0562

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE
80M03YXJ7I	VALSARTAN	137862-53-4	VALSARTAN
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
848131	amLODIPine 10 MG / valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848151	amLODIPine 10 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848135	amLODIPine 10 MG / valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848140	amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848145	amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848134	EXFORGE HCT 10 MG / 160 MG / 12.5 MG Oral Tablet	PSN	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848155	EXFORGE HCT 10 MG / 160 MG / 25 MG Oral Tablet	PSN	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848139	EXFORGE HCT 10 MG / 320 MG / 25 MG Oral Tablet	PSN	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848144	EXFORGE HCT 5 MG / 160 MG / 12.5 MG Oral Tablet	PSN	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848149	EXFORGE HCT 5 MG / 160 MG / 25 MG Oral Tablet	PSN	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848134	amlodipine 10 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet [Exforge HCT]	SBD	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848155	amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [Exforge HCT]	SBD	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848139	amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 320 MG Oral Tablet [Exforge HCT]	SBD	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848144	amlodipine 5 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet [Exforge HCT]	SBD	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848149	amlodipine 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [Exforge HCT]	SBD	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848131	amlodipine 10 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet	SCD	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848151	amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SCD	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848135	amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 320 MG Oral Tablet	SCD	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848140	amlodipine 5 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet	SCD	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848145	amlodipine 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SCD	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848131	amlodipine (as amlodipine besylate) 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848135	amlodipine (as amlodipine besylate) 10 MG / HCTZ 25 MG / valsartan 320 MG Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848151	amlodipine (as amlodipine besylate) 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848140	amlodipine (as amlodipine besylate) 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848145	amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848131	amlodipine 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848134	Amlodipine 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet [Exforge HCT]	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848151	amlodipine 10 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848155	Amlodipine 10 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet [Exforge HCT]	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848135	amlodipine 10 MG / HCTZ 25 MG / valsartan 320 MG Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848139	Amlodipine 10 MG / HCTZ 25 MG / valsartan 320 MG Oral Tablet [Exforge HCT]	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848140	amlodipine 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848144	Amlodipine 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet [Exforge HCT]	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848145	amlodipine 5 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848149	Amlodipine 5 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet [Exforge HCT]	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848134	Exforge HCT 10/160/12.5 (amlodipine / valsartan / HCTZ) Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848134	Exforge HCT 10/160/12.5 Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848155	Exforge HCT 10/160/25 (amlodipine / valsartan / HCTZ) Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848155	Exforge HCT 10/160/25 Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848139	Exforge HCT 10/320/25 (amlodipine / valsartan / HCTZ) Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848139	Exforge HCT 10/320/25 Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848144	Exforge HCT 5/160/12.5 (amlodipine / valsartan / HCTZ) Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848144	Exforge HCT 5/160/12.5 Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848149	Exforge HCT 5/160/25 (amlodipine / valsartan / HCTZ) Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33
848149	Exforge HCT 5/160/25 Oral Tablet	SY	18d7820d-471f-4ee2-9ec6-25d8d27c77de	33

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0562-15	00078056215	30 TABLET, FILM COATED in 1 BOTTLE (0078-0562-15)	2009-04-04	0000-00-00	No	No	Current
0078-0562-30	00078056230	1 in 1 BLISTER PACK					Historical