FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
55700-015
11-digit product format
557000015
Labeler code
55700
Product ID
55700-015_443f6afc-f678-4144-a5c1-b6dc7364f454
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA078414
Marketing category
ANDA
Marketing start
2010-04-07
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
10 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-015DDiscontinued by firm2026-08-03
excluded packagepackage55700-01555700-015-18DDiscontinued by firm2026-08-03
excluded packagepackage55700-01555700-015-30DDiscontinued by firm2026-08-03
excluded packagepackage55700-01555700-015-60DDiscontinued by firm2026-08-03
excluded packagepackage55700-01555700-015-90DDiscontinued by firm2026-08-03

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078414-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2010-04-07a50c72e98297…
2026-08-01 22:54:322026-06A078414-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2010-04-07a50c72e98297…
2026-08-01 22:54:322026-06A078414-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2010-04-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078414-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078414-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078414-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-015-18EA - Each55700-015260e70c6-d59b-4884-979b-4a468f03f81612017-05-04
55700-015-30EA - Each55700-015160d5b18-0483-4159-9242-1125628b3ccd12014-01-04
55700-015-60EA - Each55700-0151015d2a5-9f7e-497d-a7d2-bcd2819084a112014-01-04