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United States · US · US:64980-630_ab8a1422-3508-4480-964c-dbb6681b1428

Norepinephrine Bitartrate

Orange BookUNIISPLATC C01CA03

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

Identification

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

Packs · 1

  • ndc11
    6498063041
    10 VIAL, SINGLE-DOSE in 1 CARTON (64980-630-41) / 4 mL in 1 VIAL, SINGLE-DOSE (64980-630-04)

Annotations

UNII (FDA Substance ID)
IFY5PE3ZRW
NOREPINEPHRINE BITARTRATE
RxCUI 7508
Orange Book
A218758
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": {
    "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": "64980-630_ab8a1422-3508-4480-964c-dbb6681b1428",
  "productndc": "64980-630",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "218758",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1MG BASE/ML",
        "product_no": "001",
        "approval_date": "May 13, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NOREPINEPHRINE BITARTRATE",
  "proprietary_name": "Norepinephrine Bitartrate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA218758",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norepinephrine Bitartrate",
  "start_marketing_date": "20241101",
  "active_numerator_strength": "1"
}

Related drugs

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