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United States · US · US:0713-0851_44ea2018-99d5-8f97-e063-6294a90ab0f2
ciprofloxacin hydrochloride and hydrocortisone
Orange BookUNIISPLATC J01MA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCosette Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01MA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1107130851091 BOTTLE in 1 CARTON (0713-0851-09) / 10 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
4BA73M5E37
CIPROFLOXACIN HYDROCHLORIDE
RxCUI 81981
Orange Book
A218273
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": "0713-0851_44ea2018-99d5-8f97-e063-6294a90ab0f2",
"productndc": "0713-0851",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "218273",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.2% BASE;1%",
"product_no": "001",
"approval_date": "Nov 10, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE",
"proprietary_name": "ciprofloxacin hydrochloride and hydrocortisone",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "ANDA218273",
"marketing_category": "ANDA",
"nonproprietary_name": "ciprofloxacin hydrochloride and hydrocortisone",
"start_marketing_date": "20251204",
"active_numerator_strength": "2; 10"
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