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United States · US · US:67296-2179_44f66b04-9be9-1920-e063-6294a90a2b52
Ofloxacin
Orange BookUNIISPLATC J01MA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRedpharm Drug
CountryUS (United States)
ATC codeJ01MA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1167296217951 BOTTLE in 1 CARTON (67296-2179-5) / 5 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
A4P49JAZ9H
OFLOXACIN
RxCUI 7623
Orange Book
A216328
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": "67296-2179_44f66b04-9be9-1920-e063-6294a90a2b52",
"productndc": "67296-2179",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "216328",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.3%",
"product_no": "001",
"approval_date": "Oct 15, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OFLOXACIN",
"proprietary_name": "Ofloxacin",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA216328",
"marketing_category": "ANDA",
"nonproprietary_name": "Ofloxacin",
"start_marketing_date": "20241031",
"active_numerator_strength": "3"
}Related drugs
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- GBExocin 0.3% eye dropsLexon (UK) Ltd
- 🇪🇸EXOCIN 3 MG/ML COLIRIO EN SOLUCIONAbbvie Spain, S.L.U.
- 🇺🇸OCUFLOXAllergan, Inc.
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