AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE

Product NDC: 49884-174
11-digit product format: 498840174
Labeler code: 49884
Product ID: 49884-174_468724f1-bde7-4497-8028-915d44367e99
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amlodipine besylate valsartan hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Par Pharmaceutical, Inc.
Application: ANDA201087
Marketing category: ANDA
Marketing start: 2015-06-01
Marketing end: 2022-05-31
Substance: AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength: 10 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

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49884-174		D	Discontinued by firm	2026-08-11
excluded package	package	49884-174	49884-174-05	D	Discontinued by firm	2026-08-11
excluded package	package	49884-174	49884-174-09	D	Discontinued by firm	2026-08-11
excluded package	package	49884-174	49884-174-11	D	Discontinued by firm	2026-08-11

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 · 48 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	49884-174-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49884-174-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49884-174-11	`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	49884-174-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49884-174-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49884-174-11	`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	49884-174-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49884-174-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49884-174-11	`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	49884-174-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49884-174-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49884-174-11	`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	49884-174-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49884-174-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49884-174-11	`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	49884-174-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49884-174-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49884-174-11	`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	49884-174-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49884-174-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49884-174-11	`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	49884-174-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49884-174-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49884-174-11	`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	49884-174-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49884-174-09	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49884-174-11	`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	49884-174-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49884-174-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49884-174-11	`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	49884-174-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49884-174-09	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49884-174-11	`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	49884-174-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49884-174-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49884-174-11	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A201087-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-01
A201087-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-01
A201087-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-01
A201087-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-01
A201087-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2015-06-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A201087-001	AB
A201087-002	AB
A201087-003	AB
A201087-004	AB
A201087-005	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 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201087-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201087-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201087-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201087-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201087-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2015-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201087-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201087-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201087-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201087-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201087-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2015-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201087-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201087-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201087-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201087-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201087-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2015-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201087-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201087-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201087-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201087-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201087-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2015-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201087-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201087-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201087-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201087-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201087-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2015-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201087-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201087-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201087-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201087-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201087-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2015-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201087-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201087-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201087-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201087-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201087-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2015-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201087-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201087-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201087-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2015-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201087-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2015-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201087-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2015-06-01	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201087-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201087-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201087-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201087-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201087-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201087-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201087-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201087-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201087-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201087-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201087-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201087-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201087-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201087-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201087-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201087-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201087-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201087-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201087-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201087-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201087-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201087-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201087-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201087-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201087-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201087-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201087-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201087-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201087-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201087-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201087-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201087-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201087-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201087-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201087-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201087-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201087-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201087-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201087-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201087-005	AB	1	`5bbf6a4d5a75…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-174-09	EA - Each	49884-174	8e3a4f9b-c6d6-42fb-bb8f-5d9f002ecb6d	1	2015-07-20
49884-174-11	EA - Each	49884-174	ab4e0dbf-815a-46d8-84e9-c28994ddc9f2	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
VALSARTAN	ACTIVE INGREDIENT	80M03YXJ7I	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
VALSARTAN	ACTIVE MOIETY	80M03YXJ7I	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL INC.]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PAR PHARMACEUTICAL 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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE	Golden State Medical Supply, Inc.	e9ecbadb-c548-6fe5-e053-2a95a90a7577	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201087 application number: ANDA201087
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE	Strides Pharma Science Limited	9b76e441-e6a5-4036-8276-b7788ade5c44	2025-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201087 application number: ANDA201087

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-174-05	49884017405	500 TABLET, FILM COATED in 1 BOTTLE (49884-174-05)	2015-06-01	0000-00-00	No	No	Current
49884-174-09	49884017409	90 TABLET, FILM COATED in 1 BOTTLE (49884-174-09)	2015-06-01	2022-05-31	No	No	Current
49884-174-11	49884017411	30 TABLET, FILM COATED in 1 BOTTLE (49884-174-11)	2015-06-01	2022-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	Par Pharmaceutical, Inc. \| Par Pharmaceutical Inc.	2020-11-19	HUMAN PRESCRIPTION DRUG LABEL	11