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United States · US · US:25021-836_0cced8a7-58b3-43e5-afca-2d6d3ed4c017

Ephedrine Sulfate

Orange BookUNIISPLATC C01CA26

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeC01CA26
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2502183601
    25 VIAL in 1 CARTON (25021-836-01) / 1 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
U6X61U5ZEG
EPHEDRINE SULFATE
RxCUI 91166
Orange Book
A214528
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": "25021-836_0cced8a7-58b3-43e5-afca-2d6d3ed4c017",
  "productndc": "25021-836",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "214528",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/ML (50MG/ML)",
        "product_no": "001",
        "approval_date": "Mar 9, 2023"
      }
    ],
    "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": "ANDA214528",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ephedrine Sulfate",
  "start_marketing_date": "20230415",
  "active_numerator_strength": "50"
}

Related drugs

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