NOREPINEPHRINE BITARTRATE

Orange BookUNIISPLATC C01CA03

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

Identification

ManufacturerBaxter Healthcare Corporation

CountryUS (United States)

ATC codeC01CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0338010820
20 CONTAINER in 1 CARTON (0338-0108-20) / 250 mL in 1 CONTAINER

Annotations

UNII (FDA Substance ID)

IFY5PE3ZRW

NOREPINEPHRINE BITARTRATE

RxCUI 7508

Orange Book

N214313

APAPAP

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": "0338-0108_b40627c0-67bf-4740-9d21-83054aa6afd9",
  "productndc": "0338-0108",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "214313",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)",
        "product_no": "001",
        "approval_date": "Jan 15, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)",
        "product_no": "002",
        "approval_date": "Jan 15, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)",
        "product_no": "003",
        "approval_date": "Nov 21, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)",
        "product_no": "004",
        "approval_date": "Feb 6, 2026"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)",
        "product_no": "005",
        "approval_date": "Feb 6, 2026"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)",
        "product_no": "006",
        "approval_date": "Feb 6, 2026"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NOREPINEPHRINE BITARTRATE",
  "proprietary_name": "NOREPINEPHRINE BITARTRATE",
  "active_ingred_unit": "mg/250mL",
  "application_number": "NDA214313",
  "marketing_category": "NDA",
  "nonproprietary_name": "norepinephrine bitartrate",
  "start_marketing_date": "20210115",
  "active_numerator_strength": "8"
}

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