🇺🇸
United States · US · US:0904-7434_53a8315c-ae56-4ea0-bdab-ac0d8590d628
ofloxacin
Orange BookUNIISPLATC J01MA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeJ01MA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1109047434051 BOTTLE, DROPPER in 1 CARTON (0904-7434-05) / 5 mL in 1 BOTTLE, DROPPER
- ndc1109047434101 BOTTLE, DROPPER in 1 CARTON (0904-7434-10) / 10 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
A4P49JAZ9H
OFLOXACIN
RxCUI 7623
Orange Book
A215886
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": "0904-7434_53a8315c-ae56-4ea0-bdab-ac0d8590d628",
"productndc": "0904-7434",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "215886",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.3%",
"product_no": "001",
"approval_date": "Nov 23, 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": "ANDA215886",
"marketing_category": "ANDA",
"nonproprietary_name": "ofloxacin",
"start_marketing_date": "20241111",
"active_numerator_strength": "3"
}Related drugs
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