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United States · US · US:72241-074_5edb8648-37ed-49de-825c-a3d66e5aa4c0

OFLOXACIN

Orange BookUNIISPLATC J01MA01

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

Identification

ManufacturerModavar Pharmaceuticals LLC
CountryUS (United States)
ATC codeJ01MA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7224107402
    100 TABLET, FILM COATED in 1 BOTTLE (72241-074-02)
  • ndc11
    7224107405
    500 TABLET, FILM COATED in 1 BOTTLE (72241-074-05)
  • ndc11
    7224107410
    50 TABLET, FILM COATED in 1 BOTTLE (72241-074-10)

Annotations

UNII (FDA Substance ID)
A4P49JAZ9H
OFLOXACIN
RxCUI 7623
Orange Book
A091656
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "A4P49JAZ9H",
    "rxcui": "7623",
    "inchikey": "GSDSWSVVBLHKDQ-UHFFFAOYSA-N",
    "display_name": "OFLOXACIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d97651cc-d9ea-4be4-8ea1-3d0278582dd5": {
      "match": "brand_token",
      "title": "OFLOXACIN SOLUTION/ DROPS [REMEDYREPACK INC.]",
      "spl_version": "7",
      "published_date": "2026-04-17"
    }
  },
  "productid": "72241-074_5edb8648-37ed-49de-825c-a3d66e5aa4c0",
  "productndc": "72241-074",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091656",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Sep 18, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Sep 18, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Sep 18, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OFLOXACIN",
  "proprietary_name": "OFLOXACIN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091656",
  "marketing_category": "ANDA",
  "nonproprietary_name": "OFLOXACIN",
  "start_marketing_date": "20250624",
  "active_numerator_strength": "400"
}

Related drugs

Other records sharing ATC code J01MA01.

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