🇺🇸
United States · US · US:75834-200_991170ff-e65c-421f-b7f0-95f78e459844
OFLOXACIN
Orange BookUNIISPLATC J01MA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNivagen Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01MA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117583420001100 TABLET, COATED in 1 BOTTLE (75834-200-01)
- ndc117583420005500 TABLET, COATED in 1 BOTTLE (75834-200-05)
- ndc11758342005050 TABLET, COATED in 1 BOTTLE (75834-200-50)
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": "75834-200_991170ff-e65c-421f-b7f0-95f78e459844",
"productndc": "75834-200",
"dosage_form": "TABLET, 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": "20190125",
"active_numerator_strength": "300"
}Related drugs
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