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United States · US · US:60505-0582_1f0760bf-4dfb-6466-23d6-72770eecf10e

Moxifloxacin

In shortageOrange BookUNIISPLATC J01MA14

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

Identification

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

Packs · 1

  • ndc11
    6050505824
    1 BOTTLE, DROPPER in 1 CARTON (60505-0582-4) / 3 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
B8956S8609
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
RxCUI 1926505
Orange Book
A090080
AT1
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Moxifloxacin Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "B8956S8609",
    "rxcui": "1926505",
    "inchikey": "SKZIMSDWAIZNDD-WJMOHVQJSA-N",
    "display_name": "MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE",
    "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": "60505-0582_1f0760bf-4dfb-6466-23d6-72770eecf10e",
  "productndc": "60505-0582",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "090080",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT1",
        "strength": "EQ 0.5% BASE",
        "product_no": "001",
        "approval_date": "Jun 30, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE",
  "shortage_reason": "Moxifloxacin Injection",
  "shortage_status": "current",
  "proprietary_name": "Moxifloxacin",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA090080",
  "marketing_category": "ANDA",
  "nonproprietary_name": "moxifloxacin",
  "start_marketing_date": "20170701",
  "active_numerator_strength": "5"
}

Related drugs

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