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United States · US · US:50268-576_4ee2636f-f50a-98d3-e063-6294a90a7e15

Moxifloxacin Hydrochloride

In shortageOrange BookUNIISPLATC J01MA14

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

Identification

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

Packs · 1

  • ndc11
    5026857613
    30 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-576-13) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-576-11)

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": "50268-576_4ee2636f-f50a-98d3-e063-6294a90a7e15",
  "productndc": "50268-576",
  "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": "20160722",
  "active_numerator_strength": "400"
}

Related drugs

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