🇺🇸
United States · US · US:69315-327_f468adb2-e4c3-4c2d-ba1d-af8e9319d035
OFLOXACIN
Orange BookUNIISPLATC J01MA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLeading Pharma, LLC
CountryUS (United States)
ATC codeJ01MA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1169315327055 mL in 1 BOTTLE, DROPPER (69315-327-05)
- ndc11693153271010 mL in 1 BOTTLE, DROPPER (69315-327-10)
Annotations
UNII (FDA Substance ID)
A4P49JAZ9H
OFLOXACIN
RxCUI 7623
Orange Book
A217904
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": "OPHTHALMIC",
"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": "69315-327_f468adb2-e4c3-4c2d-ba1d-af8e9319d035",
"productndc": "69315-327",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "217904",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.3%",
"product_no": "001",
"approval_date": "Apr 12, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OFLOXACIN",
"proprietary_name": "OFLOXACIN",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA217904",
"marketing_category": "ANDA",
"nonproprietary_name": "OFLOXACIN",
"start_marketing_date": "20240715",
"active_numerator_strength": "3"
}Related drugs
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