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United States · US · US:68083-610_f743e5f5-b2bb-424d-887f-9ea5ec06ea92
Ephedrine Sulfate
Orange BookUNIISPLATC C01CA26
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeC01CA26
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11680836101010 VIAL in 1 CARTON (68083-610-10) / 10 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
U6X61U5ZEG
EPHEDRINE SULFATE
RxCUI 91166
Orange Book
A218211
AP1
DailyMed SPL labels
1 version tracked
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",
"spl_meta": {
"3e43cc8e-bf4e-44ef-a07d-4336367b9bdb": {
"match": "brand_token",
"title": "EPHEDRINE SULFATE INJECTION, SOLUTION [PAR HEALTH USA, LLC]",
"spl_version": "7",
"published_date": "2026-04-27"
}
},
"productid": "68083-610_f743e5f5-b2bb-424d-887f-9ea5ec06ea92",
"productndc": "68083-610",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "218211",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP1",
"strength": "50MG/10ML (5MG/ML)",
"product_no": "001",
"approval_date": "Jan 16, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EPHEDRINE SULFATE",
"proprietary_name": "Ephedrine Sulfate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA218211",
"marketing_category": "ANDA",
"nonproprietary_name": "Ephedrine Sulfate",
"start_marketing_date": "20250116",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C01CA26.
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