ephedrine sulfate

Orange BookUNIISPLATC C01CA26

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeC01CA26

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6521954605
10 SYRINGE, PLASTIC in 1 CARTON (65219-546-05) / 5 mL in 1 SYRINGE, PLASTIC (65219-546-01)

Annotations

UNII (FDA Substance ID)

U6X61U5ZEG

EPHEDRINE SULFATE

RxCUI 91166

Orange Book

A218271

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": "65219-546_de95d79e-ae15-4056-a4e5-ac3380768cdb",
  "productndc": "65219-546",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "218271",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP2",
        "strength": "25MG/5ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Mar 11, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP2",
        "strength": "50MG/10ML (5MG/ML)",
        "product_no": "002",
        "approval_date": "Mar 11, 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": "ANDA218271",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ephedrine sulfate",
  "start_marketing_date": "20250707",
  "active_numerator_strength": "5"
}

Related drugs

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