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United States · US · US:66298-8507_1d783072-b073-e384-e063-6394a90a7460

Moxifloxacin

In shortageOrange BookUNIISPLATC J01MA14

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

Identification

ManufacturerHp Halden Pharma AS
CountryUS (United States)
ATC codeJ01MA14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6629885074
    250 mL in 1 BAG (66298-8507-4)

Annotations

UNII (FDA Substance ID)
C53598599T
MOXIFLOXACIN HYDROCHLORIDE
RxCUI 228750
Orange Book
N205572
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Moxifloxacin Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "C53598599T",
    "rxcui": "228750",
    "inchikey": "IDIIJJHBXUESQI-DFIJPDEKSA-N",
    "display_name": "MOXIFLOXACIN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "c6fa4129-2f92-4179-ac5d-bb7b4a538789": {
      "match": "brand_token",
      "title": "MOXIFLOXACIN HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]",
      "spl_version": "9",
      "published_date": "2026-05-21"
    }
  },
  "productid": "66298-8507_1d783072-b073-e384-e063-6394a90a7460",
  "productndc": "66298-8507",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "205572",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Apr 3, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MOXIFLOXACIN HYDROCHLORIDE",
  "shortage_reason": "Moxifloxacin Injection",
  "shortage_status": "current",
  "proprietary_name": "Moxifloxacin",
  "active_ingred_unit": "mg/250mL",
  "application_number": "NDA205572",
  "marketing_category": "NDA",
  "nonproprietary_name": "MOXIFLOXACIN HYDROCHLORIDE",
  "start_marketing_date": "20170802",
  "active_numerator_strength": "400"
}

Related drugs

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