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United States · US · US:69238-1616_d15f384c-ca53-4e8c-8d50-bfa1eef73abb
Ofloxacin
Orange BookUNIISPLATC J01MA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeJ01MA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169238161661 BOTTLE, DROPPER in 1 CARTON (69238-1616-6) / 10 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
A4P49JAZ9H
OFLOXACIN
RxCUI 7623
Orange Book
A211525
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": "69238-1616_d15f384c-ca53-4e8c-8d50-bfa1eef73abb",
"productndc": "69238-1616",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "211525",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.3%",
"product_no": "001",
"approval_date": "Aug 30, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OFLOXACIN",
"proprietary_name": "Ofloxacin",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA211525",
"marketing_category": "ANDA",
"nonproprietary_name": "Ofloxacin Otic",
"start_marketing_date": "20190830",
"active_numerator_strength": "3"
}Related drugs
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