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United States · US · US:14789-250_54276f21-7800-44f4-ae51-0060fb1c43ad

Emerphed

Orange BookUNIISPLATC C01CA26

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

Identification

ManufacturerNexus Pharamaceuticals Inc.
CountryUS (United States)
ATC codeC01CA26
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1478925010
    10 VIAL in 1 CARTON (14789-250-10) / 10 mL in 1 VIAL (14789-250-07)

Annotations

UNII (FDA Substance ID)
U6X61U5ZEG
EPHEDRINE SULFATE
RxCUI 91166
Orange Book
N213407
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": {
    "14601778-93ac-43ec-b66b-5a942317133f": {
      "match": "brand_token",
      "title": "EMERPHED -PFS (EPHEDRINE SULFATE) INJECTION [NEXUS PHARMACEUTICALS, LLC]",
      "spl_version": "6",
      "published_date": "2025-04-30"
    }
  },
  "productid": "14789-250_54276f21-7800-44f4-ae51-0060fb1c43ad",
  "productndc": "14789-250",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "213407",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP1",
        "strength": "50MG/10ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Apr 17, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25MG/5ML (5MG/ML)",
        "product_no": "002",
        "approval_date": "Feb 28, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPHEDRINE SULFATE",
  "proprietary_name": "Emerphed",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA213407",
  "marketing_category": "NDA",
  "nonproprietary_name": "Ephedrine Sulfate",
  "start_marketing_date": "20200515",
  "active_numerator_strength": "5"
}

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