AMLODIPINE AND VALSARTAN

Product NDC: 43386-081
11-digit product format: 433860081
Labeler code: 43386
Product ID: 43386-081_8d66a9ba-050e-4993-939b-f2c858760a0c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amlodipine and valsartan
Dosage form: TABLET
Route: ORAL
Labeler: Lupin Pharmaceuticals,Inc.
Application: ANDA202829
Marketing category: ANDA
Marketing start: 2015-03-30
Substance: AMLODIPINE BESYLATE; VALSARTAN
Active strength: 5; 320 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

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 · 3 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	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	43386-081		E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	43386-081	43386-081-03	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	43386-081	43386-081-09	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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

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
A202829-001	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30
A202829-002	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30
A202829-003	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30
A202829-004	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202829-001	AB
A202829-002	AB
A202829-003	AB
A202829-004	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 · 164 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	A202829-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202829-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202829-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202829-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202829-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202829-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202829-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202829-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202829-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202829-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202829-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202829-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202829-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202829-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202829-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202829-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202829-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202829-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202829-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202829-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202829-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202829-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202829-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202829-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202829-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202829-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202829-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202829-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202829-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202829-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202829-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202829-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202829-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202829-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202829-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202829-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202829-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202829-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202829-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202829-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A202829-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202829-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202829-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202829-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202829-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202829-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202829-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202829-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202829-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202829-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202829-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202829-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202829-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202829-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202829-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202829-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202829-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202829-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202829-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202829-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202829-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202829-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202829-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202829-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202829-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202829-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202829-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202829-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202829-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202829-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202829-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202829-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202829-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202829-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202829-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202829-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202829-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202829-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202829-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202829-004	AB	1	`d06236e962d9…`

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	320 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
e05dd72c-7475-422e-bf8e-73148929450e	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43386-081-03	2023-01-31	C162847	48780-1	f386c64a-3a1c-0266-e053-dadaa90a7c1a	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
43386-081-09	2023-01-31	C162847	48780-1	f386c64a-3a1c-0266-e053-dadaa90a7c1a	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	Strength	SPL version
43386-081-03	AMLODIPINE AND VALSARTAN	30 in 1 BOTTLE	TABLET	30		4
43386-081-09	AMLODIPINE AND VALSARTAN	90 in 1 BOTTLE	TABLET	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43386-081-03	EA - Each	43386-081	927c919d-78bf-451f-ad65-1e9a2216fa97	1	2015-05-05
43386-081-09	EA - Each	43386-081	721bc99c-d793-4139-b2d9-4e0dd672c0dd	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]	1
VALSARTAN	ACTIVE INGREDIENT	80M03YXJ7I	AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]	1
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]	1
VALSARTAN	ACTIVE MOIETY	80M03YXJ7I	AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [GAVIS PHARMACEUTICALS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43386-081	AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [LUPIN PHARMACEUTICALS,INC.]	4	Current NDC, Legacy NDC, 2 package rows	20230201_e05dd72c-7475-422e-bf8e-73148929450e.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 AND VALSARTAN	AMLODIPINE AND VALSARTAN	Lupin Pharmaceuticals,Inc.	e05dd72c-7475-422e-bf8e-73148929450e	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202829 application number: ANDA202829 ndc (product): 43386-081

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	e05dd72c-7475-422e-bf8e-73148929450e	4
722131	amLODIPine 10 MG / valsartan 320 MG Oral Tablet	PSN	e05dd72c-7475-422e-bf8e-73148929450e	4
722134	amLODIPine 5 MG / valsartan 160 MG Oral Tablet	PSN	e05dd72c-7475-422e-bf8e-73148929450e	4
722137	amLODIPine 5 MG / valsartan 320 MG Oral Tablet	PSN	e05dd72c-7475-422e-bf8e-73148929450e	4
722126	amlodipine 10 MG / valsartan 160 MG Oral Tablet	SCD	e05dd72c-7475-422e-bf8e-73148929450e	4
722131	amlodipine 10 MG / valsartan 320 MG Oral Tablet	SCD	e05dd72c-7475-422e-bf8e-73148929450e	4
722134	amlodipine 5 MG / valsartan 160 MG Oral Tablet	SCD	e05dd72c-7475-422e-bf8e-73148929450e	4
722137	amlodipine 5 MG / valsartan 320 MG Oral Tablet	SCD	e05dd72c-7475-422e-bf8e-73148929450e	4
722126	amlodipine (as amlodipine besylate) 10 MG / valsartan 160 MG Oral Tablet	SY	e05dd72c-7475-422e-bf8e-73148929450e	4
722131	amlodipine (as amlodipine besylate) 10 MG / valsartan 320 MG Oral Tablet	SY	e05dd72c-7475-422e-bf8e-73148929450e	4
722134	amlodipine (as amlodipine besylate) 5 MG / valsartan 160 MG Oral Tablet	SY	e05dd72c-7475-422e-bf8e-73148929450e	4
722137	amlodipine (as amlodipine besylate) 5 MG / valsartan 320 MG Oral Tablet	SY	e05dd72c-7475-422e-bf8e-73148929450e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43386-081-03	43386008103	30 TABLET in 1 BOTTLE (43386-081-03)	30 tablet	2015-03-30	0000-00-00	No	No	Current
43386-081-09	43386008109	90 TABLET in 1 BOTTLE (43386-081-09)	90 tablet	2015-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMLODIPINE AND VALSARTAN	Lupin Pharmaceuticals,Inc. \| Novel Laboratories, Inc.	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	4