Amlodipine and Valsartan

Product NDC: 46708-458
11-digit product format: 467080458
Labeler code: 46708
Product ID: 46708-458_3fb35d37-f05c-44ff-be96-076adaa6da32
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine and Valsartan
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA202713
Marketing category: ANDA
Marketing start: 2016-12-01
Substance: AMLODIPINE BESYLATE; VALSARTAN
Active strength: 5; 160 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]
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202713-001	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-04-03
A202713-002	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-04-03
A202713-003	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-04-03
A202713-004	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-04-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A202713-001	AB
A202713-002	AB
A202713-003	AB
A202713-004	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 5 · 172 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	A202713-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202713-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202713-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202713-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202713-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202713-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202713-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202713-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202713-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202713-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202713-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202713-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202713-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202713-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202713-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202713-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202713-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202713-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202713-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202713-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202713-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202713-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202713-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202713-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202713-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202713-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202713-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202713-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202713-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202713-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202713-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202713-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202713-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202713-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202713-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202713-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202713-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202713-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202713-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202713-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-04-03	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A202713-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202713-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202713-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202713-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202713-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202713-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202713-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202713-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202713-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202713-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202713-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202713-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202713-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202713-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202713-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202713-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202713-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202713-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202713-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202713-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202713-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202713-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202713-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202713-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202713-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202713-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202713-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202713-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202713-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202713-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202713-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202713-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202713-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202713-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202713-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202713-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202713-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202713-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202713-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202713-004	AB	1	`5bbf6a4d5a75…`

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 and Valsartan
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMLODIPINE BESYLATE	5 mg/1
VALSARTAN	160 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
722126	Internal RxNorm lookup
722131	Internal RxNorm lookup
722134	Internal RxNorm lookup
722137	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
a9c442dc-749e-4de0-bca3-1044eb78da72	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
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
265792b3-b999-c010-7364-a7db20b9d4d9	Product name	5	20250515
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
a72887ef-d675-499f-af4b-78688f6855cd	Product name	1	20191002
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
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
bded1554-44de-900a-5297-403365d6d4b2	Product name	3	20170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1	Product name	1	20150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	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
46708-458-10	2023-01-31	These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007
46708-458-30	2023-01-31	These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007
46708-458-31	2023-01-31	These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007
46708-458-71	2023-01-31	These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007
46708-458-90	2023-01-31	These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007
46708-458-10	2023-01-30	These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007
46708-458-30	2023-01-30	These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007
46708-458-31	2023-01-30	These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007
46708-458-71	2023-01-30	These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007
46708-458-90	2023-01-30	These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS . AMLODIPINE and VALSARTAN tablets, for oral use. Initial U.S. Approval: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46708-458-10	Amlodipine and Valsartan	100 in 1 CARTON	TABLET, FILM COATED	100	3
46708-458-30	Amlodipine and Valsartan	30 in 1 BOTTLE	TABLET, FILM COATED	30	3
46708-458-31	Amlodipine and Valsartan	100 in 1 BOTTLE	TABLET, FILM COATED	100	3
46708-458-71	Amlodipine and Valsartan	500 in 1 BOTTLE	TABLET, FILM COATED	500	3
46708-458-90	Amlodipine and Valsartan	90 in 1 BOTTLE	TABLET, FILM COATED	90	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-458	AMLODIPINE AND VALSARTAN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]	3	Current NDC, Legacy NDC, 5 package rows	20230202_a9c442dc-749e-4de0-bca3-1044eb78da72.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 and Valsartan	AMLODIPINE AND VALSARTAN	Alembic Pharmaceuticals Inc.	6894085d-6076-4e2e-8105-a9bbb0bd93ef	2024-06-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202713 application number: ANDA202713
Amlodipine and Valsartan	AMLODIPINE AND VALSARTAN	Alembic Pharmaceuticals Limited	a9c442dc-749e-4de0-bca3-1044eb78da72	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202713 application number: ANDA202713 ndc (product): 46708-458

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
722126	amLODIPine 10 MG / valsartan 160 MG Oral Tablet	PSN	a9c442dc-749e-4de0-bca3-1044eb78da72	3
722131	amLODIPine 10 MG / valsartan 320 MG Oral Tablet	PSN	a9c442dc-749e-4de0-bca3-1044eb78da72	3
722134	amLODIPine 5 MG / valsartan 160 MG Oral Tablet	PSN	a9c442dc-749e-4de0-bca3-1044eb78da72	3
722137	amLODIPine 5 MG / valsartan 320 MG Oral Tablet	PSN	a9c442dc-749e-4de0-bca3-1044eb78da72	3
722126	amlodipine 10 MG / valsartan 160 MG Oral Tablet	SCD	a9c442dc-749e-4de0-bca3-1044eb78da72	3
722131	amlodipine 10 MG / valsartan 320 MG Oral Tablet	SCD	a9c442dc-749e-4de0-bca3-1044eb78da72	3
722134	amlodipine 5 MG / valsartan 160 MG Oral Tablet	SCD	a9c442dc-749e-4de0-bca3-1044eb78da72	3
722137	amlodipine 5 MG / valsartan 320 MG Oral Tablet	SCD	a9c442dc-749e-4de0-bca3-1044eb78da72	3
722126	amlodipine (as amlodipine besylate) 10 MG / valsartan 160 MG Oral Tablet	SY	a9c442dc-749e-4de0-bca3-1044eb78da72	3
722131	amlodipine (as amlodipine besylate) 10 MG / valsartan 320 MG Oral Tablet	SY	a9c442dc-749e-4de0-bca3-1044eb78da72	3
722134	amlodipine (as amlodipine besylate) 5 MG / valsartan 160 MG Oral Tablet	SY	a9c442dc-749e-4de0-bca3-1044eb78da72	3
722137	amlodipine (as amlodipine besylate) 5 MG / valsartan 320 MG Oral Tablet	SY	a9c442dc-749e-4de0-bca3-1044eb78da72	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-458-10	46708045810	100 TABLET, FILM COATED in 1 CARTON (46708-458-10)	2016-12-01	0000-00-00	No	No	Current
46708-458-30	46708045830	30 TABLET, FILM COATED in 1 BOTTLE (46708-458-30)	2016-12-01	0000-00-00	No	No	Current
46708-458-31	46708045831	100 TABLET, FILM COATED in 1 BOTTLE (46708-458-31)	2016-12-01	0000-00-00	No	No	Current
46708-458-71	46708045871	500 TABLET, FILM COATED in 1 BOTTLE (46708-458-71)	2016-12-01	0000-00-00	No	No	Current
46708-458-90	46708045890	90 TABLET, FILM COATED in 1 BOTTLE (46708-458-90)	2016-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine and Valsartan	Alembic Pharmaceuticals Limited	2023-01-27	Human Prescription Drug Label	3