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United States · US · US:65145-143_47f838f6-cc86-41f5-924a-f6f5c4ddc43e
Ofloxacin
Orange BookUNIISPLATC J01MA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCaplin Steriles Limited
CountryUS (United States)
ATC codeJ01MA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165145143011 BOTTLE, DROPPER in 1 CARTON (65145-143-01) / 5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
A4P49JAZ9H
OFLOXACIN
RxCUI 7623
Orange Book
A217903
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": "65145-143_47f838f6-cc86-41f5-924a-f6f5c4ddc43e",
"productndc": "65145-143",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "217903",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.3%",
"product_no": "001",
"approval_date": "Jan 5, 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": "ANDA217903",
"marketing_category": "ANDA",
"nonproprietary_name": "Ofloxacin Otic",
"start_marketing_date": "20241216",
"active_numerator_strength": "3"
}Related drugs
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