Back to search
🇺🇸

United States · US · US:62332-505_57885d05-de45-4be8-b01d-d3596fb8a96d

Moxifloxacin ophthalmic solution

In shortageOrange BookUNIISPLATC J01MA14

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

Identification

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

Packs · 1

  • ndc11
    6233250503
    1 BOTTLE in 1 CARTON (62332-505-03) / 3 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
C53598599T
MOXIFLOXACIN HYDROCHLORIDE
RxCUI 228750
Orange Book
A209469
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": "62332-505_57885d05-de45-4be8-b01d-d3596fb8a96d",
  "productndc": "62332-505",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "209469",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT1",
        "strength": "EQ 0.5% BASE",
        "product_no": "001",
        "approval_date": "Feb 13, 2019"
      }
    ],
    "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": "ANDA209469",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Moxifloxacin ophthalmic solution",
  "start_marketing_date": "20190213",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code J01MA14.

Access this data programmatically

Query Moxifloxacin ophthalmic solution and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.