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United States · US · US:67296-2232_51d45c8d-c77e-d974-e063-6394a90ac72c

Moxifloxacin Hydrochloride

In shortageOrange BookUNIISPLATC J01MA14

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

Identification

ManufacturerRedpharm Drug
CountryUS (United States)
ATC codeJ01MA14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6729622323
    1 BOTTLE in 1 CARTON (67296-2232-3) / 3 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
C53598599T
MOXIFLOXACIN HYDROCHLORIDE
RxCUI 228750
Orange Book
A209698
AT1
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": "OPHTHALMIC",
  "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": "67296-2232_51d45c8d-c77e-d974-e063-6394a90ac72c",
  "productndc": "67296-2232",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "209698",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT1",
        "strength": "EQ 0.5% BASE",
        "product_no": "001",
        "approval_date": "Nov 14, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MOXIFLOXACIN HYDROCHLORIDE",
  "shortage_reason": "Moxifloxacin Injection",
  "shortage_status": "current",
  "proprietary_name": "Moxifloxacin Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA209698",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Moxifloxacin Hydrochloride",
  "start_marketing_date": "20241125",
  "active_numerator_strength": "5"
}

Related drugs

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