Norepinephrine

Orange BookUNIISPLATC C01CA03

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

Identification

ManufacturerLong Grove Pharmaceuticals, LLC

CountryUS (United States)

ATC codeC01CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8129896593
10 POUCH in 1 BOX (81298-9659-3) / 1 BAG in 1 POUCH (81298-9659-1) / 250 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

IFY5PE3ZRW

NOREPINEPHRINE BITARTRATE

RxCUI 7508

Orange Book

N214628

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": "81298-9659_329c5273-4dc5-4738-bf21-660e73d91eb9",
  "productndc": "81298-9659",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "214628",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)",
        "product_no": "001",
        "approval_date": "Oct 6, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)",
        "product_no": "002",
        "approval_date": "Oct 6, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)",
        "product_no": "003",
        "approval_date": "Oct 6, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NOREPINEPHRINE BITARTRATE",
  "proprietary_name": "Norepinephrine",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA214628",
  "marketing_category": "NDA",
  "nonproprietary_name": "Norepinephrine Bitartrate",
  "start_marketing_date": "20240202",
  "active_numerator_strength": "16"
}

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