Amlodipine Besylate

Product NDC
43353-684
Requested package NDC
43353-684-15
11-digit product format
433530684
Labeler code
43353
Product ID
43353-684_1fb58ec3-f97b-443f-ada2-a8d4edaedef8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078414
Marketing category
ANDA
Marketing start
2010-04-07
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
5 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage43353-68443353-684-15DDiscontinued by firm2026-08-03

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-68443353-684-15DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-68443353-684-15DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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

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
A078414-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2010-04-07
A078414-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2010-04-07
A078414-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2010-04-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A078414-001AB
A078414-002AB
A078414-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078414-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2010-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078414-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2010-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078414-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2010-04-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078414-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2010-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078414-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2010-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078414-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2010-04-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078414-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2010-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078414-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2010-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078414-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2010-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078414-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2010-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078414-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2010-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078414-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2010-04-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078414-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2010-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078414-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2010-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078414-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2010-04-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078414-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2010-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078414-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2010-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078414-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2010-04-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078414-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2010-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078414-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2010-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078414-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2010-04-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078414-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2010-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078414-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2010-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078414-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2010-04-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078414-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2010-04-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078414-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2010-04-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078414-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2010-04-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078414-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2010-04-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A078414-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2010-04-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A078414-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2010-04-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078414-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2010-04-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078414-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2010-04-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078414-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2010-04-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078414-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2010-04-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078414-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2010-04-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078414-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2010-04-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078414-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2010-04-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078414-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2010-04-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078414-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2010-04-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078414-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2010-04-078072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078414-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078414-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078414-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078414-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078414-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078414-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078414-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078414-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078414-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078414-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078414-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078414-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078414-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078414-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078414-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078414-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078414-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078414-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078414-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078414-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078414-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078414-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078414-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078414-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078414-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078414-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078414-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078414-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078414-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078414-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078414-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078414-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078414-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078414-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078414-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078414-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078414-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078414-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078414-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078414-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-684-15EA - Each43353-684a710cc18-ac84-41e0-988d-cdddb46c71c512014-06-03
43353-684-30EA - Each43353-684b54d3ba5-2519-4d15-bbd8-f4ae6b4c13cd12014-06-03
43353-684-45EA - Each43353-6840c37cf3d-b1e5-42a9-9034-35f96ba79c0e12014-06-03
43353-684-60EA - Each43353-6842db2f056-7588-4e12-ac6d-5e20388b067f12017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-684AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC20171026_6e83de08-b0f6-492a-a2db-e8d33a7a28aa.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATEPD-Rx Pharmaceuticals, Inc.1080fcea-a5da-499d-a855-690c135590712026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414
AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATEOxford Pharmaceuticals, LLC6f20efca-943b-4bc2-a157-0931bd4d45852026-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414
AMLODIPINE BESYLATE 10 mgAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.ea9f44a1-96cf-496a-8c07-18d8de27e5122026-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414
AMLODIPINE BESYLATE 5 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC49104797-8202-1376-e063-6294a90adb382026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414
AMLODIPINE BESYLATE 10 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC47e494d2-8971-3f8f-e063-6394a90adb202026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414
AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATEProficient Rx LP6313edc5-d2d5-44a1-a06f-7f7829c870d22025-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414
AMLODIPINE BESYLATE 10 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC1871ddaf-ed2c-c3ce-e063-6394a90a1bee2024-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414
AMLODIPINE BESYLATE 10 mgAMLODIPINE BESYLATENuCare Pharmaceuticals,Inc.ffe96aa1-db66-33e4-e053-6394a90a7e4e2024-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414
AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC132c078d-7d31-a6f2-e063-6294a90af0952024-03-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414
AMLODIPINE BESYLATE 5 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCb597d1e1-aba1-4272-bed7-4c95e8150d582023-04-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078414
application number: ANDA078414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-684-154335306841515 TABLET in 1 BOTTLE, PLASTIC (43353-684-15) 15 tablet2011-06-060000-00-00NoNoCurrent