🇺🇸
United States · US · US:72241-074_5edb8648-37ed-49de-825c-a3d66e5aa4c0
OFLOXACIN
Orange BookUNIISPLATC J01MA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerModavar Pharmaceuticals LLC
CountryUS (United States)
ATC codeJ01MA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117224107402100 TABLET, FILM COATED in 1 BOTTLE (72241-074-02)
- ndc117224107405500 TABLET, FILM COATED in 1 BOTTLE (72241-074-05)
- ndc11722410741050 TABLET, FILM COATED in 1 BOTTLE (72241-074-10)
Annotations
UNII (FDA Substance ID)
A4P49JAZ9H
OFLOXACIN
RxCUI 7623
Orange Book
A091656
ABABAB
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": "ORAL",
"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": "72241-074_5edb8648-37ed-49de-825c-a3d66e5aa4c0",
"productndc": "72241-074",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "091656",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Sep 18, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Sep 18, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "003",
"approval_date": "Sep 18, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OFLOXACIN",
"proprietary_name": "OFLOXACIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091656",
"marketing_category": "ANDA",
"nonproprietary_name": "OFLOXACIN",
"start_marketing_date": "20250624",
"active_numerator_strength": "400"
}Related drugs
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