EPHEDRINE SULFATE

Orange BookUNIISPLATC C01CA26

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPar Health USA, LLC

CountryUS (United States)

ATC codeC01CA26

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4202324399
10 mL in 1 VIAL, SINGLE-DOSE (42023-243-99)

Annotations

UNII (FDA Substance ID)

U6X61U5ZEG

EPHEDRINE SULFATE

RxCUI 91166

Orange Book

N213994

AP2AP2

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": "42023-243_d5d83f67-f892-44ca-aae7-8f380171266a",
  "productndc": "42023-243",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "213994",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP2",
        "strength": "50MG/10ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Oct 16, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP2",
        "strength": "25MG/5ML (5MG/ML)",
        "product_no": "002",
        "approval_date": "Apr 22, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPHEDRINE SULFATE",
  "proprietary_name": "EPHEDRINE SULFATE",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA213994",
  "marketing_category": "NDA",
  "nonproprietary_name": "Ephedrine Sulfate",
  "start_marketing_date": "20240131",
  "active_numerator_strength": "5"
}

Related drugs

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