🇺🇸
United States · US · US:59390-140_28125c1a-d1b0-4763-9b5e-07b4cfc2d889
Ofloxacin ophthalmic
Orange BookUNIISPLATC J01MA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAltaire Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ01MA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159390140055 mL in 1 BOTTLE, DROPPER (59390-140-05)
Annotations
UNII (FDA Substance ID)
A4P49JAZ9H
OFLOXACIN
RxCUI 7623
Orange Book
A202692
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": "59390-140_28125c1a-d1b0-4763-9b5e-07b4cfc2d889",
"productndc": "59390-140",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "202692",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.3%",
"product_no": "001",
"approval_date": "Apr 29, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OFLOXACIN",
"proprietary_name": "Ofloxacin ophthalmic",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA202692",
"marketing_category": "ANDA",
"nonproprietary_name": "Ofloxacin",
"start_marketing_date": "20130531",
"active_numerator_strength": "3"
}Related drugs
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