AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE

Product NDC: 64380-197
Requested package NDC: 64380-197-02
11-digit product format: 643800197
Labeler code: 64380
Product ID: 64380-197_6c98cab6-e7ba-42ba-adf9-71fa67c0a403
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amlodipine besylate valsartan hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Strides Pharma Science Limited
Application: ANDA201087
Marketing category: ANDA
Marketing start: 2022-06-27
Substance: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Active strength: 5; 12.5; 160 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

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64380-197	64380-197-02	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMLODIPINE BESYLATE	5 mg/1
VALSARTAN	12.5 mg/1
HYDROCHLOROTHIAZIDE	160 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
0J48LPH2TH	Internal UNII lookup
80M03YXJ7I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
848131	Internal RxNorm lookup
848135	Internal RxNorm lookup
848140	Internal RxNorm lookup
848145	Internal RxNorm lookup
848151	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
9b76e441-e6a5-4036-8276-b7788ade5c44	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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64380-197-01	2024-04-24	These highlights do not include all the information needed to use AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE safely and effectively. See full prescribing information for AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE. AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2009
64380-197-02	2024-04-24	These highlights do not include all the information needed to use AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE safely and effectively. See full prescribing information for AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE. AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2009
64380-197-03	2024-04-24	These highlights do not include all the information needed to use AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE safely and effectively. See full prescribing information for AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE. AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2009
64380-197-01	2024-01-30	These highlights do not include all the information needed to use AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE safely and effectively. See full prescribing information for AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE. AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2009
64380-197-02	2024-01-30	These highlights do not include all the information needed to use AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE safely and effectively. See full prescribing information for AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE. AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2009
64380-197-03	2024-01-30	These highlights do not include all the information needed to use AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE safely and effectively. See full prescribing information for AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE. AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64380-197-01	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30	6
64380-197-02	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	90 in 1 BOTTLE	TABLET, FILM COATED	90	6
64380-197-03	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	500 in 1 BOTTLE	TABLET, FILM COATED	500	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64380-197-01	EA - Each	64380-197	09b3a064-02a9-45a6-95d0-68a376252c5b	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64380-197	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED]	6	Current NDC, Legacy NDC, 3 package rows	20250411_9b76e441-e6a5-4036-8276-b7788ade5c44.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 · 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 ndc (package): 64380-197-02 ndc (product): 64380-197 ndc11 (package): 64380019702

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

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	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848151	amLODIPine 10 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848135	amLODIPine 10 MG / valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848140	amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848145	amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848131	amlodipine 10 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet	SCD	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848151	amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SCD	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848135	amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 320 MG Oral Tablet	SCD	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848140	amlodipine 5 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet	SCD	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848145	amlodipine 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SCD	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848131	amlodipine (as amlodipine besylate) 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848135	amlodipine (as amlodipine besylate) 10 MG / HCTZ 25 MG / valsartan 320 MG Oral Tablet	SY	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848151	amlodipine (as amlodipine besylate) 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SY	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848140	amlodipine (as amlodipine besylate) 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848145	amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SY	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848131	amlodipine 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848151	amlodipine 10 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet	SY	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848135	amlodipine 10 MG / HCTZ 25 MG / valsartan 320 MG Oral Tablet	SY	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848140	amlodipine 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848145	amlodipine 5 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet	SY	9b76e441-e6a5-4036-8276-b7788ade5c44	6
848131	amLODIPine 10 MG / valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3
848151	amLODIPine 10 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3
848135	amLODIPine 10 MG / valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3
848140	amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3
848145	amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3
848131	amlodipine 10 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet	SCD	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3
848151	amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SCD	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3
848135	amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 320 MG Oral Tablet	SCD	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3
848140	amlodipine 5 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet	SCD	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3
848145	amlodipine 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SCD	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3
848131	amlodipine (as amlodipine besylate) 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3
848135	amlodipine (as amlodipine besylate) 10 MG / HCTZ 25 MG / valsartan 320 MG Oral Tablet	SY	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3
848151	amlodipine (as amlodipine besylate) 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SY	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3
848140	amlodipine (as amlodipine besylate) 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3
848145	amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SY	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3
848131	amlodipine 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3
848151	amlodipine 10 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet	SY	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3
848135	amlodipine 10 MG / HCTZ 25 MG / valsartan 320 MG Oral Tablet	SY	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3
848140	amlodipine 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3
848145	amlodipine 5 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet	SY	e9ecbadb-c548-6fe5-e053-2a95a90a7577	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64380-197-02	64380019702	90 TABLET, FILM COATED in 1 BOTTLE (64380-197-02)	2022-06-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	Golden State Medical Supply, Inc.	2025-06-02	HUMAN PRESCRIPTION DRUG LABEL	3
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	Strides Pharma Science Limited	2025-04-10	HUMAN PRESCRIPTION DRUG LABEL	6