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United States · US · US:63187-268_331a9c17-9946-48a6-bc37-af84ecdea26a
Ofloxacin
Orange BookUNIISPLATC J01MA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ01MA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163187268051 BOTTLE, DROPPER in 1 CARTON (63187-268-05) / 5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
A4P49JAZ9H
OFLOXACIN
RxCUI 7623
Orange Book
A076622
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": "63187-268_331a9c17-9946-48a6-bc37-af84ecdea26a",
"productndc": "63187-268",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "076622",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.3%",
"product_no": "001",
"approval_date": "May 14, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OFLOXACIN",
"proprietary_name": "Ofloxacin",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA076622",
"marketing_category": "ANDA",
"nonproprietary_name": "Ofloxacin",
"start_marketing_date": "20040514",
"active_numerator_strength": "3"
}Related drugs
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