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United States · US · US:55111-112_b7966736-4865-d3ad-d218-886c8a286492

Moxifloxacin

In shortageOrange BookUNIISPLATC J01MA14

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

Identification

ManufacturerDr. Reddy's Laboratories Limited
CountryUS (United States)
ATC codeJ01MA14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    5511111201
    100 TABLET, FILM COATED in 1 BOTTLE (55111-112-01)
  • ndc11
    5511111205
    500 TABLET, FILM COATED in 1 BOTTLE (55111-112-05)
  • ndc11
    5511111230
    30 TABLET, FILM COATED in 1 BOTTLE (55111-112-30)
  • ndc11
    5511111266
    5 BLISTER PACK in 1 CARTON (55111-112-66) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-112-79)

Annotations

UNII (FDA Substance ID)
C53598599T
MOXIFLOXACIN HYDROCHLORIDE
RxCUI 228750
Orange Book
A076938
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": "55111-112_b7966736-4865-d3ad-d218-886c8a286492",
  "productndc": "55111-112",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076938",
    "products": [
      {
        "rs": true,
        "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",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076938",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Moxifloxacin",
  "start_marketing_date": "20140305",
  "active_numerator_strength": "400"
}

Related drugs

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