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United States · US · US:70127-100_4552ca49-8f8c-418f-9029-03f6eda8a7b5
Epidiolex
Orange BookUNIISPLATC N03AX24
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJazz Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN03AX24
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1170127100101 BOTTLE, GLASS in 1 CARTON (70127-100-10) / 100 mL in 1 BOTTLE, GLASS (70127-100-01)
- ndc1170127100601 BOTTLE, GLASS in 1 CARTON (70127-100-60) / 60 mL in 1 BOTTLE, GLASS (70127-100-06)
Annotations
UNII (FDA Substance ID)
19GBJ60SN5
CANNABIDIOL
RxCUI 2045371
Orange Book
N210365
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "19GBJ60SN5",
"rxcui": "2045371",
"inchikey": "QHMBSVQNZZTUGM-ZWKOTPCHSA-N",
"display_name": "CANNABIDIOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"8bf27097-4870-43fb-94f0-f3d0871d1eec": {
"match": "brand_token",
"title": "EPIDIOLEX (CANNABIDIOL) SOLUTION [JAZZ PHARMACEUTICALS, INC.]",
"spl_version": "34",
"published_date": "2025-11-17"
}
},
"productid": "70127-100_4552ca49-8f8c-418f-9029-03f6eda8a7b5",
"productndc": "70127-100",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "210365",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG/ML",
"product_no": "001",
"approval_date": "Sep 28, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CANNABIDIOL",
"proprietary_name": "Epidiolex",
"active_ingred_unit": "mg/mL",
"application_number": "NDA210365",
"marketing_category": "NDA",
"nonproprietary_name": "cannabidiol",
"start_marketing_date": "20181005",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N03AX24.
- GBCannabidiol 200mg/ml oral solutionSpecial Order
- NOCannabidiol glostrupGlostrup Apotek
- NOCannabidiol glostrupGlostrup Apotek
- NOCannabidiol glostrupGlostrup Apotek
- NOCannabidiol glostrupGlostrup Apotek
- CAEPIDIOLEXJAZZ PHARMACEUTICALS RESEARCH UK LIMITED
- GBEpidiolex 100mg/ml oral solutionJazz Pharmaceuticals Operations UK Ltd
- GBEpidiolex 25mg/ml oral solutionJazz Pharmaceuticals Operations UK Ltd
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