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United States · US · US:0904-7407_eeab280e-fdca-45ae-b2ae-325799c9c3ff

MOXIFLOXACIN HYDROCHLORIDE

In shortageOrange BookUNIISPLATC J01MA14

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

Identification

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

Packs · 2

  • ndc11
    0904740704
    30 BLISTER PACK in 1 CARTON (0904-7407-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    0904740706
    50 BLISTER PACK in 1 CARTON (0904-7407-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
C53598599T
MOXIFLOXACIN HYDROCHLORIDE
RxCUI 228750
Orange Book
A202632
AB
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": "ORAL",
  "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": "0904-7407_eeab280e-fdca-45ae-b2ae-325799c9c3ff",
  "productndc": "0904-7407",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202632",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 400MG BASE",
        "product_no": "001",
        "approval_date": "Mar 4, 2014"
      }
    ],
    "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/1",
  "application_number": "ANDA202632",
  "marketing_category": "ANDA",
  "nonproprietary_name": "moxifloxacin hydrochloride",
  "start_marketing_date": "20240308",
  "active_numerator_strength": "400"
}

Related drugs

Other records sharing ATC code J01MA14.

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