amlodipine,valsartan and hydrochlorothiazide

Product NDC: 33342-283
11-digit product format: 333420283
Labeler code: 33342
Product ID: 33342-283_1ea4f227-b97a-49f1-bbc3-1dede2c1866d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amlodipine,valsartan and hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Macleods Pharmaceuticals Limited
Application: ANDA207299
Marketing category: ANDA
Marketing start: 2025-01-06
Substance: AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength: 5; 160; 12.5 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

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	Approval date
A207299-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2025-01-07
A207299-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2025-01-07
A207299-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2025-01-07
A207299-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2025-01-07
A207299-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2025-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207299-001	AB
A207299-002	AB
A207299-003	AB
A207299-004	AB
A207299-005	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 2 · 45 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
2026-09-14 22:38:34	2026-08	A207299-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2025-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207299-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2025-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207299-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2025-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207299-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2025-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207299-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2025-01-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207299-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2025-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207299-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2025-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207299-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2025-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207299-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2025-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207299-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2025-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207299-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2025-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207299-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2025-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207299-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2025-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207299-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2025-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207299-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2025-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207299-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2025-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207299-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2025-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207299-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2025-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207299-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2025-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207299-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2025-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207299-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2025-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207299-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2025-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207299-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2025-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207299-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2025-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207299-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2025-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207299-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2025-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207299-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2025-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207299-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2025-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207299-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2025-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207299-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2025-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207299-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2025-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207299-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2025-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207299-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2025-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207299-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2025-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207299-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2025-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207299-001	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2025-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207299-002	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	2025-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207299-003	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	2025-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207299-004	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	2025-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207299-005	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	2025-01-07	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 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	A207299-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207299-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207299-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207299-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207299-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207299-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207299-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207299-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207299-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207299-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207299-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207299-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207299-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207299-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207299-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207299-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207299-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207299-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207299-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207299-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207299-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207299-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207299-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207299-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207299-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207299-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207299-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207299-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207299-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207299-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207299-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207299-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207299-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207299-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207299-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207299-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207299-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207299-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207299-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207299-005	AB	1	`03ed91905a0d…`

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: amlodipine,valsartan and hydrochlorothiazide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMLODIPINE BESYLATE	5 mg/1
VALSARTAN	160 mg/1
HYDROCHLOROTHIAZIDE	12.5 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 · 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
1ea4f227-b97a-49f1-bbc3-1dede2c1866d	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
33342-283-07	amlodipine,valsartan and hydrochlorothiazide	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
33342-283-10	amlodipine,valsartan and hydrochlorothiazide	90 in 1 BOTTLE	TABLET, FILM COATED	90	1
33342-283-12	amlodipine,valsartan and hydrochlorothiazide	10 in 1 CARTON	TABLET, FILM COATED	10	1
33342-283-12	amlodipine,valsartan and hydrochlorothiazide	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33342-283-07	EA - Each	33342-283	9da1853c-d160-4122-9f37-19f15c0d6589	1	2025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33342-283	AMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]	1	Current NDC, 4 package rows	20250112_1ea4f227-b97a-49f1-bbc3-1dede2c1866d.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
amlodipine,valsartan and hydrochlorothiazide	AMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDE	Macleods Pharmaceuticals Limited	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207299 application number: ANDA207299 ndc (product): 33342-283

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	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1
848151	amLODIPine 10 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1
848135	amLODIPine 10 MG / valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1
848140	amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1
848145	amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1
848131	amlodipine 10 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet	SCD	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1
848151	amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SCD	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1
848135	amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 320 MG Oral Tablet	SCD	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1
848140	amlodipine 5 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet	SCD	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1
848145	amlodipine 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SCD	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1
848131	amlodipine (as amlodipine besylate) 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1
848135	amlodipine (as amlodipine besylate) 10 MG / HCTZ 25 MG / valsartan 320 MG Oral Tablet	SY	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1
848151	amlodipine (as amlodipine besylate) 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SY	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1
848140	amlodipine (as amlodipine besylate) 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1
848145	amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SY	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1
848131	amlodipine 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1
848151	amlodipine 10 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet	SY	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1
848135	amlodipine 10 MG / HCTZ 25 MG / valsartan 320 MG Oral Tablet	SY	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1
848140	amlodipine 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1
848145	amlodipine 5 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet	SY	1ea4f227-b97a-49f1-bbc3-1dede2c1866d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
33342-283-07	33342028307	30 TABLET, FILM COATED in 1 BOTTLE (33342-283-07)		2025-01-06	No	No	Current
33342-283-10	33342028310	90 TABLET, FILM COATED in 1 BOTTLE (33342-283-10)		2025-01-06	No	No	Current
33342-283-12	33342028312	10 BLISTER PACK in 1 CARTON (33342-283-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2025-01-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
amlodipine,valsartan and hydrochlorothiazide	Macleods Pharmaceuticals Limited	2025-01-09	Human Prescription Drug Label	1