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United States · US · US:72485-613_086cc6db-b800-dc8f-e063-6294a90a4196
Ofloxacin
Orange BookUNIISPLATC J01MA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerARMAS PHARMACEUTICALS INC.
CountryUS (United States)
ATC codeJ01MA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1172485613101 BOTTLE, DROPPER in 1 CARTON (72485-613-10) / 5 mL in 1 BOTTLE, DROPPER
- ndc1172485613111 BOTTLE, DROPPER in 1 CARTON (72485-613-11) / 10 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
A4P49JAZ9H
OFLOXACIN
RxCUI 7623
Orange Book
A076407
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": "72485-613_086cc6db-b800-dc8f-e063-6294a90a4196",
"productndc": "72485-613",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "076407",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.3%",
"product_no": "001",
"approval_date": "Apr 15, 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": "ANDA076407",
"marketing_category": "ANDA",
"nonproprietary_name": "Ofloxacin",
"start_marketing_date": "20231014",
"active_numerator_strength": "3"
}Related drugs
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