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United States · US · US:72485-625_0a5b0305-9f16-b6a0-e063-6294a90aef9a
Ciprofloxacin and dexamethasone
Orange BookUNIISPLATC J01MA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerARMAS PHARMACEUTICALS INC.
CountryUS (United States)
ATC codeJ01MA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172485625131 BOTTLE, DROPPER in 1 CARTON (72485-625-13) / 7.5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
4BA73M5E37
CIPROFLOXACIN HYDROCHLORIDE
RxCUI 81981
Orange Book
A215768
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4BA73M5E37",
"rxcui": "81981",
"inchikey": "ARPUHYJMCVWYCZ-UHFFFAOYSA-N",
"display_name": "CIPROFLOXACIN HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "AURICULAR (OTIC)",
"spl_meta": {
"a05035e1-f941-4f7c-9321-91dd50ab149b": {
"match": "brand_token",
"title": "CIPROFLOXACIN TABLET, COATED [BRYANT RANCH PREPACK]",
"spl_version": "104",
"published_date": "2026-06-01"
}
},
"productid": "72485-625_0a5b0305-9f16-b6a0-e063-6294a90aef9a",
"productndc": "72485-625",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "215768",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.3%;0.1%",
"product_no": "001",
"approval_date": "Jun 9, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE",
"proprietary_name": "Ciprofloxacin and dexamethasone",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "ANDA215768",
"marketing_category": "ANDA",
"nonproprietary_name": "Ciprofloxacin and dexamethasone",
"start_marketing_date": "20231101",
"active_numerator_strength": "3; 1"
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