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United States · US · US:51754-4200_5a627a89-7997-4af5-a1d0-2cedbe1bc868
Akovaz
Orange BookUNIIATC C01CA26
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerExela Pharma Sciences, LLC
CountryUS (United States)
ATC codeC01CA26
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11517544200425 VIAL, SINGLE-DOSE in 1 CARTON (51754-4200-4) / 1 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
U6X61U5ZEG
EPHEDRINE SULFATE
RxCUI 91166
Orange Book
N208289
APAP3
Raw payload (JSON)
{
"unii": {
"unii": "U6X61U5ZEG",
"rxcui": "91166",
"inchikey": "CAVQBDOACNULDN-KHFUBBAMSA-N",
"display_name": "EPHEDRINE SULFATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"productid": "51754-4200_5a627a89-7997-4af5-a1d0-2cedbe1bc868",
"productndc": "51754-4200",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "208289",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "50MG/ML (50MG/ML)",
"product_no": "001",
"approval_date": "Apr 29, 2016"
},
{
"rs": true,
"rld": true,
"te_code": "AP3",
"strength": "25MG/5ML (5MG/ML)",
"product_no": "002",
"approval_date": "Aug 2, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EPHEDRINE SULFATE",
"proprietary_name": "Akovaz",
"active_ingred_unit": "mg/mL",
"application_number": "NDA208289",
"marketing_category": "NDA",
"nonproprietary_name": "ephedrine sulfate",
"start_marketing_date": "20210415",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code C01CA26.
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