Amlodipine and Valsartan

Product NDC
0093-7692
11-digit product format
000937692
Labeler code
0093
Product ID
0093-7692_7daefded-c14c-491b-bcd7-78de21562ae2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA091235
Marketing category
ANDA
Marketing start
2015-03-30
Marketing end
2019-04-30
Substance
AMLODIPINE BESYLATE; VALSARTAN
Active strength
5 mg/1; mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0093-7692DDiscontinued by firm2026-10-05
excluded packagepackage0093-76920093-7692-56DDiscontinued by firm2026-10-05
excluded packagepackage0093-76920093-7692-98DDiscontinued by firm2026-10-05

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-7692-56d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-7692-98d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-7692-56f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-7692-98f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-7692-562ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-7692-982ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-7692-56a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-7692-98a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-7692-56cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-7692-98cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-7692-56cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-7692-98cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-7692-56302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-7692-98302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-7692-56ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-7692-98ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-7692-560efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-7692-980efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-7692-56ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-7692-98ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-7692-56367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-7692-98367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-7692-56557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-7692-98557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091235-001AMLODIPINE BESYLATE AND VALSARTANAMLODIPINE BESYLATE; VALSARTANEQ 5MG BASE;160MGTABLET / ORAL2015-03-30
A091235-002AMLODIPINE BESYLATE AND VALSARTANAMLODIPINE BESYLATE; VALSARTANEQ 10MG BASE;160MGTABLET / ORAL2015-03-30
A091235-003AMLODIPINE BESYLATE AND VALSARTANAMLODIPINE BESYLATE; VALSARTANEQ 5MG BASE;320MGTABLET / ORAL2015-03-30
A091235-004AMLODIPINE BESYLATE AND VALSARTANAMLODIPINE BESYLATE; VALSARTANEQ 10MG BASE;320MGTABLET / ORAL2015-03-30

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091235-001AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;160MGTABLET / ORAL2015-03-3084e616aacf4f…
2026-09-14 22:38:342026-08A091235-002AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;160MGTABLET / ORAL2015-03-3084e616aacf4f…
2026-09-14 22:38:342026-08A091235-003AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;320MGTABLET / ORAL2015-03-3084e616aacf4f…
2026-09-14 22:38:342026-08A091235-004AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;320MGTABLET / ORAL2015-03-3084e616aacf4f…
2026-08-18 06:07:402026-07A091235-001AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;160MGTABLET / ORAL2015-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07A091235-002AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;160MGTABLET / ORAL2015-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07A091235-003AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;320MGTABLET / ORAL2015-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07A091235-004AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;320MGTABLET / ORAL2015-03-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091235-001AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;160MGTABLET / ORAL2015-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091235-002AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;160MGTABLET / ORAL2015-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091235-003AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;320MGTABLET / ORAL2015-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091235-004AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;320MGTABLET / ORAL2015-03-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091235-001AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;160MGTABLET / ORAL2015-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091235-002AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;160MGTABLET / ORAL2015-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091235-003AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;320MGTABLET / ORAL2015-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091235-004AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;320MGTABLET / ORAL2015-03-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A091235-001AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;160MGTABLET / ORAL2015-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091235-002AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;160MGTABLET / ORAL2015-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091235-003AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;320MGTABLET / ORAL2015-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091235-004AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;320MGTABLET / ORAL2015-03-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091235-001AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;160MGTABLET / ORAL2015-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091235-002AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;160MGTABLET / ORAL2015-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091235-003AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;320MGTABLET / ORAL2015-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091235-004AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;320MGTABLET / ORAL2015-03-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091235-001AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;160MGTABLET / ORAL2015-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091235-002AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;160MGTABLET / ORAL2015-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091235-003AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;320MGTABLET / ORAL2015-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091235-004AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;320MGTABLET / ORAL2015-03-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091235-001AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;160MGTABLET / ORAL2015-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091235-002AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;160MGTABLET / ORAL2015-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091235-003AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;320MGTABLET / ORAL2015-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091235-004AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;320MGTABLET / ORAL2015-03-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091235-001AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;160MGTABLET / ORAL2015-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091235-002AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;160MGTABLET / ORAL2015-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091235-003AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;320MGTABLET / ORAL2015-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091235-004AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;320MGTABLET / ORAL2015-03-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091235-001AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;160MGTABLET / ORAL2015-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091235-002AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;160MGTABLET / ORAL2015-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091235-003AMLODIPINE BESYLATE AND VALSARTANEQ 5MG BASE;320MGTABLET / ORAL2015-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091235-004AMLODIPINE BESYLATE AND VALSARTANEQ 10MG BASE;320MGTABLET / ORAL2015-03-305bbf6a4d5a75…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07A091235-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091235-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091235-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091235-004AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7692-56EA - Each0093-7692a2b9d04d-ce24-4843-910c-bb2ff007db6d12015-04-03
0093-7692-98EA - Each0093-7692b87dc7fb-bb68-424d-b2fa-73dc9f40208112015-04-03