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United States · US · US:72266-158_3a227739-e57d-10aa-e063-6294a90ac95e

Moxifloxacin Ophthalmic Solution

In shortageOrange BookUNIISPLATC J01MA14

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

Identification

ManufacturerFosun Pharma USA Inc.
CountryUS (United States)
ATC codeJ01MA14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7226615801
    1 BOTTLE in 1 CARTON (72266-158-01) / 3 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
C53598599T
MOXIFLOXACIN HYDROCHLORIDE
RxCUI 228750
Orange Book
A208778
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": "72266-158_3a227739-e57d-10aa-e063-6294a90ac95e",
  "productndc": "72266-158",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "208778",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT1",
        "strength": "EQ 0.5% BASE",
        "product_no": "001",
        "approval_date": "Mar 30, 2020"
      }
    ],
    "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 Ophthalmic Solution",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA208778",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Moxifloxacin Ophthalmic",
  "start_marketing_date": "20200824",
  "active_numerator_strength": "5"
}

Related drugs

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