AMLODIPINE BESYLATE 10 mg
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- AMLODIPINE BESYLATE 10 mg
- Generic name
- AMLODIPINE BESYLATE
- Manufacturer
- Aphena Pharma Solutions - Tennessee, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 47e494d2-8971-3f8f-e063-6394a90adb20
- SPL ID
- 47e48dff-09df-2ea2-e063-6394a90a8e41
- Version
- 1
- Effective date
- 2026-01-08
- Source export date
- 2026-10-12
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:13:07
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 078414 | derived:openfda.application_number |
| application number | ANDA078414 | openfda.application_number | |
| brand name | AMLODIPINE BESYLATE 10 mg | openfda.brand_name | |
| generic name | AMLODIPINE BESYLATE | openfda.generic_name | |
| manufacturer name | Aphena Pharma Solutions - Tennessee, LLC | openfda.manufacturer_name | |
| ndc | package | 71610-978-45 | openfda.package_ndc |
| ndc | package | 71610-978-60 | openfda.package_ndc |
| ndc | package | 71610-978-30 | openfda.package_ndc |
| ndc | package | 71610-978-53 | openfda.package_ndc |
| ndc | product | 71610-978 | openfda.product_ndc |
| ndc11 | package | 71610097830 | derived:openfda.package_ndc |
| ndc11 | package | 71610097860 | derived:openfda.package_ndc |
| ndc11 | package | 71610097845 | derived:openfda.package_ndc |
| ndc11 | package | 71610097853 | derived:openfda.package_ndc |
| rxcui | 308135 | openfda.rxcui | |
| spl id | 47e48dff-09df-2ea2-e063-6394a90a8e41 | id | |
| spl set id | 47e494d2-8971-3f8f-e063-6394a90adb20 | set_id | |
| unii | 864V2Q084H | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
5 WARNINGS AND PRECAUTIONS Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely. ( 5.1 ) Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine besylate tablets, particularly in patients with severe obstructive coronary artery disease. ( 5.2 ) Titrate slowly in patients with severe hepatic impairment. ( 5.3 ) 5.1 Hypotension Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely. 5.2 Increased Angina or Myocardial Infarction Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine besylate tablets, particularly in patients with severe obstructive coronary artery disease. 5.3 Patients with Hepatic Failure Because amlodipine besylate tablets are extensively metabolized by the liver and the plasma elimination half-life (t 1/2 ) is 56 hours in patients with impaired hepatic function, titrate slowly when administering amlodipine to patients with severe hepatic impairment.
warnings and cautions
5.1 Hypotension Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.
warnings and cautions
5.2 Increased Angina or Myocardial Infarction Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine besylate tablets, particularly in patients with severe obstructive coronary artery disease.
warnings and cautions
5.3 Patients with Hepatic Failure Because amlodipine besylate tablets are extensively metabolized by the liver and the plasma elimination half-life (t 1/2 ) is 56 hours in patients with impaired hepatic function, titrate slowly when administering amlodipine to patients with severe hepatic impairment.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions table
<table ID="SPLSERV-2a5df20c-cba1-4439-a5ff-cc1d33a881cb" width="621px"><caption/><col align="left"/><col align="center"/><col align="center"/><col align="center"/><col align="center"/><tbody><tr><td align="left"> </td><td align="center" colspan="2">Amlodipine besylate tablets </td><td align="center" colspan="2">Placebo </td></tr><tr><td align="left"> </td><td align="center">Male=% (N=1218) </td><td align="center">Female=% (N=512) </td><td align="center">Male=% (N=914) </td><td align="center">Female=% (N=336) </td></tr><tr><td align="left"> Edema</td><td align="center">5.6</td><td align="center">14.6</td><td align="center">1.4</td><td align="center">5.1</td></tr><tr><td align="left"> Flushing</td><td align="center">1.5</td><td align="center">4.5</td><td align="center">0.3</td><td align="center">0.9</td></tr><tr><td align="left"> Palpitations</td><td align="center">1.4</td><td align="center">3.3</td><td align="center">0.9</td><td align="center">0.9</td></tr><tr><td align="left"> Somnolence</td><td align="center">1.3</td><td align="center">1.6</td><td align="center">0.8</td><td align="center">0.3</td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.