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United States · US · US:69315-331_14b4bf1f-07ed-4578-96ac-47fc9c7c058b
GATIFLOXACIN
Orange BookUNIISPLATC S01AE06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLeading Pharma, LLC
CountryUS (United States)
ATC codeS01AE06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169315331022.5 mL in 1 BOTTLE (69315-331-02)
Annotations
UNII (FDA Substance ID)
81485Y3A9A
GATIFLOXACIN ANHYDROUS
RxCUI 1546025
Orange Book
A213542
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "81485Y3A9A",
"rxcui": "1546025",
"inchikey": "XUBOMFCQGDBHNK-UHFFFAOYSA-N",
"display_name": "GATIFLOXACIN ANHYDROUS",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"2dc44fc5-b7fc-40ec-8e9b-d86fae1fc523": {
"match": "brand_token",
"title": "GATIFLOXACIN OPHTHALMIC SOLUTION 0.5% SOLUTION [CAPLIN STERILES LIMITED]",
"spl_version": "1",
"published_date": "2025-11-17"
}
},
"productid": "69315-331_14b4bf1f-07ed-4578-96ac-47fc9c7c058b",
"productndc": "69315-331",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "213542",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.5%",
"product_no": "001",
"approval_date": "Nov 3, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GATIFLOXACIN ANHYDROUS",
"proprietary_name": "GATIFLOXACIN",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA213542",
"marketing_category": "ANDA",
"nonproprietary_name": "GATIFLOXACIN",
"start_marketing_date": "20251006",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code S01AE06.
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