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United States · US · US:0781-6186_39a8b845-aa32-4c9d-bef8-18cea1ef7bc9
Ciprofloxacin and Dexamethasone
Orange BookUNIISPLATC J01MA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeJ01MA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1107816186671 BOTTLE, DROPPER in 1 CARTON (0781-6186-67) / 7.5 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
4BA73M5E37
CIPROFLOXACIN HYDROCHLORIDE
RxCUI 81981
Orange Book
N021537
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": "0781-6186_39a8b845-aa32-4c9d-bef8-18cea1ef7bc9",
"productndc": "0781-6186",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "021537",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.3%;0.1%",
"product_no": "001",
"approval_date": "Jul 18, 2003"
}
],
"appl_type": "N"
},
"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": "NDA021537",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "ciprofloxacin and dexamethasone",
"start_marketing_date": "20200810",
"active_numerator_strength": "3; 1"
}Related drugs
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