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United States · US · US:61314-672_20dfbbfa-5c67-4ac4-a90a-a7dd29395e71
Gatifloxacin
Orange BookUNIISPLATC S01AE06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeS01AE06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1161314672251 BOTTLE, DROPPER in 1 CARTON (61314-672-25) / 2.5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
L4618BD7KJ
GATIFLOXACIN
RxCUI 228476
Orange Book
A204227
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "L4618BD7KJ",
"rxcui": "228476",
"inchikey": "RMJMZKDEVNTXHE-UHFFFAOYSA-N",
"display_name": "GATIFLOXACIN",
"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": "61314-672_20dfbbfa-5c67-4ac4-a90a-a7dd29395e71",
"productndc": "61314-672",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "204227",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "0.5%",
"product_no": "001",
"approval_date": "Jul 11, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GATIFLOXACIN",
"proprietary_name": "Gatifloxacin",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA204227",
"marketing_category": "ANDA",
"nonproprietary_name": "gatifloxacin",
"start_marketing_date": "20161003",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code S01AE06.
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