Amiodarone hydrochloride
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
- Amiodarone hydrochloride
- Generic name
- AMIODARONE HYDROCHLORIDE
- Manufacturer
- Zydus Lifesciences Limited
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 3e8db251-e3c5-4fba-be9a-6044a92f0beb
- SPL ID
- aabb5533-5d41-49a3-b8b6-14627af57311
- Version
- 10
- Effective date
- 2024-11-25
- Source export date
- 2026-11-06
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/d05434af5edc4383b7c7894a8f2d94df21171d17714450933cecdfc35cedfa3d/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 06:42:44
| 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 | 079029 | derived:openfda.application_number |
| application number | ANDA079029 | openfda.application_number | |
| brand name | Amiodarone hydrochloride | openfda.brand_name | |
| generic name | AMIODARONE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Zydus Lifesciences Limited | openfda.manufacturer_name | |
| ndc | package | 65841-631-14 | openfda.package_ndc |
| ndc | package | 65841-841-06 | openfda.package_ndc |
| ndc | package | 65841-631-05 | openfda.package_ndc |
| ndc | package | 65841-840-06 | openfda.package_ndc |
| ndc | package | 65841-631-10 | openfda.package_ndc |
| ndc | package | 65841-631-77 | openfda.package_ndc |
| ndc | package | 65841-631-06 | openfda.package_ndc |
| ndc | product | 65841-840 | openfda.product_ndc |
| ndc | product | 65841-841 | openfda.product_ndc |
| ndc | product | 65841-631 | openfda.product_ndc |
| ndc11 | package | 65841063114 | derived:openfda.package_ndc |
| ndc11 | package | 65841063110 | derived:openfda.package_ndc |
| ndc11 | package | 65841063105 | derived:openfda.package_ndc |
| ndc11 | package | 65841084006 | derived:openfda.package_ndc |
| ndc11 | package | 65841063106 | derived:openfda.package_ndc |
| ndc11 | package | 65841063177 | derived:openfda.package_ndc |
| ndc11 | package | 65841084106 | derived:openfda.package_ndc |
| rxcui | 833528 | openfda.rxcui | |
| rxcui | 834348 | openfda.rxcui | |
| rxcui | 835956 | openfda.rxcui | |
| spl id | aabb5533-5d41-49a3-b8b6-14627af57311 | id | |
| spl set id | 3e8db251-e3c5-4fba-be9a-6044a92f0beb | set_id | |
| unii | 976728SY6Z | openfda.unii |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.