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United States · US · US:65145-207_2dc44fc5-b7fc-40ec-8e9b-d86fae1fc523
Gatifloxacin Ophthalmic Solution 0.5%
Orange BookUNIISPLATC S01AE06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCaplin Steriles Limited
CountryUS (United States)
ATC codeS01AE06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165145207011 BOTTLE in 1 CARTON (65145-207-01) / 2.5 mL in 1 BOTTLE
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": "65145-207_2dc44fc5-b7fc-40ec-8e9b-d86fae1fc523",
"productndc": "65145-207",
"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 Ophthalmic Solution 0.5%",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA213542",
"marketing_category": "ANDA",
"nonproprietary_name": "Gatifloxacin Ophthalmic Solution 0.5%",
"start_marketing_date": "20251006",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code S01AE06.
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