Isotretinoin
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
- Isotretinoin
- Generic name
- ISOTRETINOIN
- Manufacturer
- Zydus Lifesciences Limited
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- dae33df0-386c-4db5-9759-7096e770ed17
- SPL ID
- b071eb5c-28f7-4b86-b4e9-7c98da2f19df
- Version
- 2
- Effective date
- 2024-11-30
- Source export date
- 2026-09-28
- 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/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:57:42
| 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 | 211568 | derived:openfda.application_number |
| application number | ANDA211568 | openfda.application_number | |
| brand name | Isotretinoin | openfda.brand_name | |
| generic name | ISOTRETINOIN | openfda.generic_name | |
| manufacturer name | Zydus Lifesciences Limited | openfda.manufacturer_name | |
| ndc | package | 70771-1560-4 | openfda.package_ndc |
| ndc | package | 70771-1559-8 | openfda.package_ndc |
| ndc | package | 70771-1558-8 | openfda.package_ndc |
| ndc | package | 70771-1557-4 | openfda.package_ndc |
| ndc | package | 70771-1558-4 | openfda.package_ndc |
| ndc | package | 70771-1557-8 | openfda.package_ndc |
| ndc | package | 70771-1560-8 | openfda.package_ndc |
| ndc | product | 70771-1559 | openfda.product_ndc |
| ndc | product | 70771-1557 | openfda.product_ndc |
| ndc | product | 70771-1558 | openfda.product_ndc |
| ndc | product | 70771-1560 | openfda.product_ndc |
| ndc11 | package | 70771155908 | derived:openfda.package_ndc |
| ndc11 | package | 70771156008 | derived:openfda.package_ndc |
| ndc11 | package | 70771155704 | derived:openfda.package_ndc |
| ndc11 | package | 70771156004 | derived:openfda.package_ndc |
| ndc11 | package | 70771155808 | derived:openfda.package_ndc |
| ndc11 | package | 70771155708 | derived:openfda.package_ndc |
| ndc11 | package | 70771155804 | derived:openfda.package_ndc |
| rxcui | 197844 | openfda.rxcui | |
| rxcui | 197845 | openfda.rxcui | |
| rxcui | 403930 | openfda.rxcui | |
| rxcui | 197843 | openfda.rxcui | |
| spl id | b071eb5c-28f7-4b86-b4e9-7c98da2f19df | id | |
| spl set id | dae33df0-386c-4db5-9759-7096e770ed17 | set_id | |
| unii | EH28UP18IF | openfda.unii |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.