Amlodipine, Valsartan and Hydrochlorothiazide

Product NDC: 13668-325
11-digit product format: 136680325
Labeler code: 13668
Product ID: 13668-325_95a9b357-3047-0ed6-e053-2995a90aff61
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine, Valsartan and Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA201593
Marketing category: ANDA
Marketing start: 2015-06-03
Marketing end: 2020-01-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	13668-325		D	Discontinued by firm	2026-08-10
excluded package	package	13668-325	13668-325-01	D	Discontinued by firm	2026-08-10
excluded package	package	13668-325	13668-325-05	D	Discontinued by firm	2026-08-10
excluded package	package	13668-325	13668-325-30	D	Discontinued by firm	2026-08-10
excluded package	package	13668-325	13668-325-74	D	Discontinued by firm	2026-08-10

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 · 60 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	13668-325-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-325-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-325-74	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-325-30	`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	13668-325-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-325-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-325-74	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-325-30	`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	13668-325-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-325-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-325-74	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-325-30	`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	13668-325-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-325-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-325-74	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-325-30	`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	13668-325-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-325-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-325-74	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-325-30	`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	13668-325-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13668-325-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13668-325-74	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13668-325-30	`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	13668-325-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13668-325-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13668-325-74	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13668-325-30	`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	13668-325-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13668-325-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13668-325-74	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13668-325-30	`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	13668-325-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13668-325-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13668-325-74	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13668-325-30	`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	13668-325-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13668-325-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13668-325-74	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13668-325-30	`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	13668-325-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13668-325-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13668-325-74	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13668-325-30	`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	13668-325-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	13668-325-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	13668-325-74	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	13668-325-30	`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	Approval date
A201593-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03
A201593-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03
A201593-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03
A201593-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03
A201593-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	2015-06-03

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201593-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201593-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201593-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201593-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201593-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	2015-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201593-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201593-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201593-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201593-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201593-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	2015-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201593-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201593-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201593-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201593-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201593-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	2015-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201593-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201593-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201593-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201593-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201593-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	2015-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201593-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201593-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201593-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201593-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201593-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	2015-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201593-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201593-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201593-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201593-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201593-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	2015-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201593-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201593-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201593-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201593-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201593-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	2015-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201593-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201593-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201593-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	2015-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201593-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	2015-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201593-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	2015-06-03	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A201593-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201593-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201593-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201593-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201593-005	AB	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A201593-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201593-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201593-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201593-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201593-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201593-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201593-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201593-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201593-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201593-005	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-325-30	EA - Each	13668-325	ac7cbce2-b6d2-4470-b1d8-0e803f204cc1	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 AND HYDROCHLOROTHIAZIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	2
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	2
VALSARTAN	ACTIVE INGREDIENT	80M03YXJ7I	AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	2
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	2
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	2
VALSARTAN	ACTIVE MOIETY	80M03YXJ7I	AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	2

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine, Valsartan and Hydrochlorothiazide	REMEDYREPACK INC.	2020-03-27	HUMAN PRESCRIPTION DRUG LABEL	4
Amlodipine, Valsartan and Hydrochlorothiazide	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2019-10-24	HUMAN PRESCRIPTION DRUG LABEL	4