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United States · US · US:0832-1430_cb253483-143c-48a2-995e-0322ec4be81c
Ciprofloxacin and Dexamethasone
Orange BookUNIISPLATC J01MA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeJ01MA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1108321430751 BOTTLE in 1 CARTON (0832-1430-75) / 7.5 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
4BA73M5E37
CIPROFLOXACIN HYDROCHLORIDE
RxCUI 81981
Orange Book
A216487
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": "0832-1430_cb253483-143c-48a2-995e-0322ec4be81c",
"productndc": "0832-1430",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "216487",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.3%;0.1%",
"product_no": "001",
"approval_date": "Jan 6, 2026"
}
],
"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": "ANDA216487",
"marketing_category": "ANDA",
"nonproprietary_name": "Ciprofloxacin Hydrochloride and Dexamethasone",
"start_marketing_date": "20260106",
"active_numerator_strength": "3; 1"
}Related drugs
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