NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE

Orange BookUNIISPLATC C01CA03

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

Identification

ManufacturerWG Critical Care, LLC

CountryUS (United States)

ATC codeC01CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4456764110
10 BAG in 1 CARTON (44567-641-10) / 250 mL in 1 BAG (44567-641-01)

Annotations

UNII (FDA Substance ID)

IFY5PE3ZRW

NOREPINEPHRINE BITARTRATE

RxCUI 7508

Orange Book

N215700

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": {
    "ddbef60d-c20a-4ada-928f-e87074c08a54": {
      "match": "brand_token",
      "title": "NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE (NOREPINEPHRINE BITARTRATE) INJECTION, SOLUTION [WG CRITICAL CARE, LLC]",
      "spl_version": "10",
      "published_date": "2026-02-18"
    }
  },
  "productid": "44567-641_a0cf3162-9ed3-4774-a076-fc8af5bbe3d0",
  "productndc": "44567-641",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "215700",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)",
        "product_no": "001",
        "approval_date": "Sep 15, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)",
        "product_no": "002",
        "approval_date": "Sep 15, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)",
        "product_no": "003",
        "approval_date": "Sep 15, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 32MG BASE/250ML (EQ 128MCG BASE/ML)",
        "product_no": "004",
        "approval_date": "Oct 15, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NOREPINEPHRINE BITARTRATE",
  "proprietary_name": "NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA215700",
  "marketing_category": "NDA",
  "nonproprietary_name": "NOREPINEPHRINE BITARTRATE",
  "start_marketing_date": "20220915",
  "active_numerator_strength": ".032"
}

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