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United States · US · US:24208-410_3f88eb9b-9978-4379-b034-92c45b6c259c

Ofloxacin

Orange BookUNIISPLATC J01MA01

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

Identification

ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeJ01MA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2420841005
    1 BOTTLE, DROPPER in 1 CARTON (24208-410-05) / 5 mL in 1 BOTTLE, DROPPER
  • ndc11
    2420841010
    1 BOTTLE, DROPPER in 1 CARTON (24208-410-10) / 10 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
A4P49JAZ9H
OFLOXACIN
RxCUI 7623
Orange Book
A076128
AT
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": "AURICULAR (OTIC)",
  "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": "24208-410_3f88eb9b-9978-4379-b034-92c45b6c259c",
  "productndc": "24208-410",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "076128",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AT",
        "strength": "0.3%",
        "product_no": "001",
        "approval_date": "Mar 17, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OFLOXACIN",
  "proprietary_name": "Ofloxacin",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA076128",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ofloxacin",
  "start_marketing_date": "20080317",
  "active_numerator_strength": "3"
}

Related drugs

Other records sharing ATC code J01MA01.

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