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
- 245898e5-3a61-4d6a-8375-8b3a8b7364ac
- SPL ID
- 26618883-d91c-476e-b22c-4d0e204b9dd3
- Version
- 1
- Effective date
- 2025-06-04
- Source export date
- 2026-10-12
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:44:42
| 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 | 216633 | derived:openfda.application_number |
| application number | ANDA216633 | 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 | 70771-1664-8 | openfda.package_ndc |
| ndc | package | 70771-1665-2 | openfda.package_ndc |
| ndc | package | 70771-1662-8 | openfda.package_ndc |
| ndc | package | 70771-1663-8 | openfda.package_ndc |
| ndc | package | 70771-1663-2 | openfda.package_ndc |
| ndc | package | 70771-1662-2 | openfda.package_ndc |
| ndc | package | 70771-1666-8 | openfda.package_ndc |
| ndc | package | 70771-1667-2 | openfda.package_ndc |
| ndc | package | 70771-1664-2 | openfda.package_ndc |
| ndc | package | 70771-1665-8 | openfda.package_ndc |
| ndc | package | 70771-1667-8 | openfda.package_ndc |
| ndc | package | 70771-1666-2 | openfda.package_ndc |
| ndc | product | 70771-1666 | openfda.product_ndc |
| ndc | product | 70771-1663 | openfda.product_ndc |
| ndc | product | 70771-1664 | openfda.product_ndc |
| ndc | product | 70771-1665 | openfda.product_ndc |
| ndc | product | 70771-1662 | openfda.product_ndc |
| ndc | product | 70771-1667 | openfda.product_ndc |
| ndc11 | package | 70771166402 | derived:openfda.package_ndc |
| ndc11 | package | 70771166208 | derived:openfda.package_ndc |
| ndc11 | package | 70771166608 | derived:openfda.package_ndc |
| ndc11 | package | 70771166602 | derived:openfda.package_ndc |
| ndc11 | package | 70771166508 | derived:openfda.package_ndc |
| ndc11 | package | 70771166702 | derived:openfda.package_ndc |
| ndc11 | package | 70771166502 | derived:openfda.package_ndc |
| ndc11 | package | 70771166202 | derived:openfda.package_ndc |
| ndc11 | package | 70771166408 | derived:openfda.package_ndc |
| ndc11 | package | 70771166302 | derived:openfda.package_ndc |
| ndc11 | package | 70771166308 | derived:openfda.package_ndc |
| ndc11 | package | 70771166708 | derived:openfda.package_ndc |
| rxcui | 197844 | openfda.rxcui | |
| rxcui | 197845 | openfda.rxcui | |
| rxcui | 1547565 | openfda.rxcui | |
| rxcui | 403930 | openfda.rxcui | |
| rxcui | 197843 | openfda.rxcui |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.