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United States · US · US:70069-819_320a0a1f-18e3-4bdb-8856-965f403666ba

EPHEDRINE SULFATE

Orange BookUNIISPLATC C01CA26

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

Identification

ManufacturerSomerset Therapeutics, LLC
CountryUS (United States)
ATC codeC01CA26
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7006981910
    10 VIAL in 1 CARTON (70069-819-10) / 1 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
U6X61U5ZEG
EPHEDRINE SULFATE
RxCUI 91166
Orange Book
A216146
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": "70069-819_320a0a1f-18e3-4bdb-8856-965f403666ba",
  "productndc": "70069-819",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216146",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/ML (50MG/ML)",
        "product_no": "001",
        "approval_date": "Feb 25, 2022"
      }
    ],
    "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": "ANDA216146",
  "marketing_category": "ANDA",
  "nonproprietary_name": "EPHEDRINE SULFATE",
  "start_marketing_date": "20241107",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code C01CA26.

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