FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
0615-8282
11-digit product format
006158282
Labeler code
0615
Product ID
0615-8282_88f5a456-f60e-49ce-92fa-cb7e82f7624b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA077516
Marketing category
ANDA
Marketing start
2011-04-15
Marketing end
2024-04-30
Substance
AMLODIPINE BESYLATE
Active strength
3 mg/1
Pharmacologic classes
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
0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-8282DDiscontinued by firm2026-07-31
excluded packagepackage0615-82820615-8282-05DDiscontinued by firm2026-07-31
excluded packagepackage0615-82820615-8282-30DDiscontinued by firm2026-07-31
excluded packagepackage0615-82820615-8282-39DDiscontinued by firm2026-07-31

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
A077516-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-11
A077516-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-11
A077516-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-11

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 22:54:322026-06A077516-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-11a50c72e98297…
2026-08-01 22:54:322026-06A077516-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-11a50c72e98297…
2026-08-01 22:54:322026-06A077516-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-11a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMLODIPINE BESYLATEAMLODIPINE BESYLATEBryant Ranch Prepackcb3da88f-cee0-4c22-9760-a50edc8fc1402023-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077516
application number: ANDA077516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8282-050061582820515 TABLET in 1 BLISTER PACK (0615-8282-05) 15 tablet2020-02-172024-04-30NoNoCurrent
0615-8282-30006158282306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8282-30) > 5 TABLET in 1 BLISTER PACK6 blister pack2019-04-042024-04-30NoNoCurrent
0615-8282-390061582823930 TABLET in 1 BLISTER PACK (0615-8282-39) 30 tablet2019-03-182024-04-30NoNoCurrent