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United States · US · US:0641-6238_355370f0-4f22-42cf-92c4-fda0763ccc2e
Ephedrine Sulfate
Orange BookUNIISPLATC C01CA26
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeC01CA26
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11064162382525 VIAL, SINGLE-DOSE in 1 CARTON (0641-6238-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6238-01)
Annotations
UNII (FDA Substance ID)
U6X61U5ZEG
EPHEDRINE SULFATE
RxCUI 91166
Orange Book
A214334
AP
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": "0641-6238_355370f0-4f22-42cf-92c4-fda0763ccc2e",
"productndc": "0641-6238",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "214334",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "50MG/ML (50MG/ML)",
"product_no": "001",
"approval_date": "Dec 15, 2020"
}
],
"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": "ANDA214334",
"marketing_category": "ANDA",
"nonproprietary_name": "Ephedrine Sulfate",
"start_marketing_date": "20201215",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code C01CA26.
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