Amlodipine Besylate

Product NDC
0378-5208
11-digit product format
003785208
Labeler code
0378
Product ID
0378-5208_2bca2c4d-60f5-438a-951c-c9ef69f98d48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076418
Marketing category
ANDA
Marketing start
2005-10-03
Marketing end
2020-06-30
Substance
AMLODIPINE BESYLATE
Active strength
3 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
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 productproduct0378-5208DDiscontinued by firm2026-08-17
excluded packagepackage0378-52080378-5208-05DDiscontinued by firm2026-08-17
excluded packagepackage0378-52080378-5208-77DDiscontinued by firm2026-08-17

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 packagepackage0378-5208-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0378-5208-77d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-5208-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-5208-77f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-5208-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-5208-772ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-5208-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-5208-77a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-5208-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-5208-77cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-5208-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-5208-77cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-5208-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-5208-77302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-5208-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-5208-77ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-5208-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-5208-770efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-5208-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-5208-77ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-5208-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-5208-77367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-5208-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-5208-77557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076418-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-03
A076418-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-03
A076418-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-03

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-03caaa826d4ba7…
2026-08-18 06:07:402026-07A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-03caaa826d4ba7…
2026-08-18 06:07:402026-07A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076418-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076418-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076418-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-031e350fbaab3a…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076418-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076418-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076418-003AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A076418-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076418-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076418-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076418-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076418-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076418-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076418-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076418-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076418-003AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-5208-05EA - Each0378-52088cd7aad4-929d-4e39-8c9e-fe3703c448bd12012-07-24
0378-5208-77EA - Each0378-5208ae604906-6183-4911-9bf6-625241b53fdc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]8
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]8
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]8
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]8
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [MYLAN PHARMACEUTICALS INC.]6
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [MYLAN PHARMACEUTICALS INC.]6
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [MYLAN PHARMACEUTICALS INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [MYLAN PHARMACEUTICALS INC.]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMLODIPINE BESYLATE TABLET [MYLAN PHARMACEUTICALS INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [MYLAN PHARMACEUTICALS INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE TABLET [MYLAN PHARMACEUTICALS INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMLODIPINE BESYLATE TABLET [MYLAN PHARMACEUTICALS INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [MYLAN PHARMACEUTICALS INC.]6