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United States · US · US:70121-1576_0d4141ef-d701-496b-a84a-a4c49b3d0767

Norepinephrine Bitartrate

Orange BookUNIISPLATC C01CA03

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

Identification

ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeC01CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7012115767
    10 VIAL in 1 CARTON (70121-1576-7) / 4 mL in 1 VIAL (70121-1576-1)

Annotations

UNII (FDA Substance ID)
IFY5PE3ZRW
NOREPINEPHRINE BITARTRATE
RxCUI 7508
Orange Book
A210839
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": "70121-1576_0d4141ef-d701-496b-a84a-a4c49b3d0767",
  "productndc": "70121-1576",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "210839",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1MG BASE/ML",
        "product_no": "001",
        "approval_date": "Dec 17, 2018"
      }
    ],
    "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": "ANDA210839",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norepinephrine Bitartrate",
  "start_marketing_date": "20181217",
  "active_numerator_strength": "1"
}

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