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United States · US · US:70518-3984_3f8f78f1-534a-08e7-e063-6294a90a6718
ofloxacin
Orange BookUNIISPLATC J01MA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeJ01MA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170518398405 mL in 1 BOTTLE, DROPPER (70518-3984-0)
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": {
"d97651cc-d9ea-4be4-8ea1-3d0278582dd5": {
"match": "brand_token",
"title": "OFLOXACIN SOLUTION/ DROPS [REMEDYREPACK INC.]",
"spl_version": "7",
"published_date": "2026-04-17"
}
},
"productid": "70518-3984_3f8f78f1-534a-08e7-e063-6294a90a6718",
"productndc": "70518-3984",
"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": "ofloxacin",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA216130",
"marketing_category": "ANDA",
"nonproprietary_name": "ofloxacin otic",
"start_marketing_date": "20240114",
"active_numerator_strength": "3"
}Related drugs
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