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United States · US · US:76420-273_e80fc4b5-cf91-6430-e053-2995a90a8128
CIPRO
Orange BookUNIISPLATC J01MA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeJ01MA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11764202731010 mL in 1 BOTTLE (76420-273-10)
Annotations
UNII (FDA Substance ID)
4BA73M5E37
CIPROFLOXACIN HYDROCHLORIDE
RxCUI 81981
Orange Book
N020805
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": {
"888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0": {
"match": "brand_token",
"title": "CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
"spl_version": "32",
"published_date": "2026-03-04"
}
},
"productid": "76420-273_e80fc4b5-cf91-6430-e053-2995a90a8128",
"productndc": "76420-273",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "020805",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 0.2% BASE;1%",
"product_no": "001",
"approval_date": "Feb 10, 1998"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE",
"proprietary_name": "CIPRO",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "NDA020805",
"marketing_category": "NDA",
"nonproprietary_name": "ciprofloxacin hydrochloride and hydrocortisone",
"start_marketing_date": "19990315",
"active_numerator_strength": "2; 10"
}Related drugs
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