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United States · US · US:72189-490_4d3aa53c-878c-d447-e063-6394a90a6a31
Olfoxacin Otic Soln
Orange BookUNIISPLATC J01MA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDirect_Rx
CountryUS (United States)
ATC codeJ01MA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172189490055 mL in 1 BOTTLE, DROPPER (72189-490-05)
Annotations
UNII (FDA Substance ID)
A4P49JAZ9H
OFLOXACIN
RxCUI 7623
Orange Book
A216130
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": {
"fda35d37-f36a-efc8-e053-6294a90a2bb8": {
"match": "brand_token",
"title": "OLFOXACIN OTIC SOLN SOLUTION [DIRECT_RX]",
"spl_version": "3",
"published_date": "2026-03-18"
}
},
"productid": "72189-490_4d3aa53c-878c-d447-e063-6394a90a6a31",
"productndc": "72189-490",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "216130",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.3%",
"product_no": "001",
"approval_date": "Jul 14, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OFLOXACIN",
"proprietary_name": "Olfoxacin Otic Soln",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA216130",
"marketing_category": "ANDA",
"nonproprietary_name": "Olfoxacin Otic Soln",
"start_marketing_date": "20230608",
"active_numerator_strength": "3"
}Related drugs
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