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United States · US · US:0409-3375_38def44d-751b-4f6c-9f00-b2bcf6988821

LEVOPHED

Orange BookUNIISPLATC C01CA03

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

Identification

ManufacturerHospira, Inc.
CountryUS (United States)
ATC codeC01CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0409337504
    10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3375-04) / 4 mL in 1 VIAL, SINGLE-DOSE (0409-3375-14)

Annotations

UNII (FDA Substance ID)
IFY5PE3ZRW
NOREPINEPHRINE BITARTRATE
RxCUI 7508
Orange Book
N007513
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "IFY5PE3ZRW",
    "rxcui": "7508",
    "inchikey": "LNBCGLZYLJMGKP-LUDZCAPTSA-N",
    "display_name": "NOREPINEPHRINE BITARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "c4de72a8-2a75-4984-ce90-e4870226dc12": {
      "match": "brand_token",
      "title": "LEVOPHED (NOREPINEPHRINE BITARTRATE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]",
      "spl_version": "20",
      "published_date": "2025-06-13"
    }
  },
  "productid": "0409-3375_38def44d-751b-4f6c-9f00-b2bcf6988821",
  "productndc": "0409-3375",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "007513",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 1MG BASE/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NOREPINEPHRINE BITARTRATE",
  "proprietary_name": "LEVOPHED",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA007513",
  "marketing_category": "NDA",
  "nonproprietary_name": "NOREPINEPHRINE BITARTRATE",
  "start_marketing_date": "20090427",
  "active_numerator_strength": "1"
}

Related drugs

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