AMLODIPINE AND VALSARTAN

Product NDC: 0378-1724
11-digit product format: 003781724
Labeler code: 0378
Product ID: 0378-1724_97bfe7c1-7e4b-45a1-b045-ff48275f1488
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMLODIPINE AND VALSARTAN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA090483
Marketing category: ANDA
Marketing start: 2015-03-30
Substance: AMLODIPINE BESYLATE; VALSARTAN
Active strength: 10; 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

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
A090483-001	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30
A090483-002	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30
A090483-003	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30
A090483-004	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
A090483-001	AB
A090483-002	AB
A090483-003	AB
A090483-004	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	A090483-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090483-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090483-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090483-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090483-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090483-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090483-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090483-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090483-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090483-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090483-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090483-004	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	A090483-001	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	A090483-002	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	A090483-003	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	A090483-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090483-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090483-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090483-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090483-004	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	A090483-001	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	A090483-002	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	A090483-003	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	A090483-004	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	A090483-001	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	A090483-002	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	A090483-003	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	A090483-004	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	A090483-001	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	A090483-002	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	A090483-003	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	A090483-004	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	A090483-001	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	A090483-002	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	A090483-003	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	A090483-004	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	A090483-001	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	A090483-002	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	A090483-003	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	A090483-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`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	A090483-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090483-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090483-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090483-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090483-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090483-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090483-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090483-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090483-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090483-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090483-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090483-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090483-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090483-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090483-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090483-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090483-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090483-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090483-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090483-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090483-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090483-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090483-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090483-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090483-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090483-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090483-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090483-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090483-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090483-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090483-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090483-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090483-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090483-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090483-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090483-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090483-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090483-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090483-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090483-004	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	10 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
aa7e7d95-520a-461c-b1b3-e588aeb6a613	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-1724-93	AMLODIPINE AND VALSARTAN	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-1724-93	EA - Each	0378-1724	06f2dc7e-124e-4275-92d0-d07eb39fe55e	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	1
VALSARTAN	ACTIVE INGREDIENT	80M03YXJ7I	AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	1
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	1
VALSARTAN	ACTIVE MOIETY	80M03YXJ7I	AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	1
SODIUM STARCH GLYCOLATE TYPE B POTATO	INACTIVE INGREDIENT	27NA468985	AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMLODIPINE BESYLATE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-1724	AMLODIPINE AND VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	6	Current NDC, Legacy NDC, 1 package rows	20240712_aa7e7d95-520a-461c-b1b3-e588aeb6a613.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	Mylan Pharmaceuticals Inc.	aa7e7d95-520a-461c-b1b3-e588aeb6a613	2021-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090483 application number: ANDA090483 ndc (product): 0378-1724

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	aa7e7d95-520a-461c-b1b3-e588aeb6a613	6
722131	amLODIPine 10 MG / valsartan 320 MG Oral Tablet	PSN	aa7e7d95-520a-461c-b1b3-e588aeb6a613	6
722134	amLODIPine 5 MG / valsartan 160 MG Oral Tablet	PSN	aa7e7d95-520a-461c-b1b3-e588aeb6a613	6
722137	amLODIPine 5 MG / valsartan 320 MG Oral Tablet	PSN	aa7e7d95-520a-461c-b1b3-e588aeb6a613	6
722126	amlodipine 10 MG / valsartan 160 MG Oral Tablet	SCD	aa7e7d95-520a-461c-b1b3-e588aeb6a613	6
722131	amlodipine 10 MG / valsartan 320 MG Oral Tablet	SCD	aa7e7d95-520a-461c-b1b3-e588aeb6a613	6
722134	amlodipine 5 MG / valsartan 160 MG Oral Tablet	SCD	aa7e7d95-520a-461c-b1b3-e588aeb6a613	6
722137	amlodipine 5 MG / valsartan 320 MG Oral Tablet	SCD	aa7e7d95-520a-461c-b1b3-e588aeb6a613	6
722126	amlodipine (as amlodipine besylate) 10 MG / valsartan 160 MG Oral Tablet	SY	aa7e7d95-520a-461c-b1b3-e588aeb6a613	6
722131	amlodipine (as amlodipine besylate) 10 MG / valsartan 320 MG Oral Tablet	SY	aa7e7d95-520a-461c-b1b3-e588aeb6a613	6
722134	amlodipine (as amlodipine besylate) 5 MG / valsartan 160 MG Oral Tablet	SY	aa7e7d95-520a-461c-b1b3-e588aeb6a613	6
722137	amlodipine (as amlodipine besylate) 5 MG / valsartan 320 MG Oral Tablet	SY	aa7e7d95-520a-461c-b1b3-e588aeb6a613	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-1724-93	00378172493	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1724-93)	2015-03-30	0000-00-00	No	No	Current