ciprofloxacin hydrochloride and hydrocortisone (0713-0851)

Drug Facts

Product Profile

Brand Name ciprofloxacin hydrochloride and hydrocortisone

Generic Name ciprofloxacin hydrochloride and hydrocortisone

Labeler cosette pharmaceuticals, inc.

Dosage Form SUSPENSION/ DROPS

Routes

AURICULAR (OTIC)

Active Ingredients

ciprofloxacin hydrochloride 2 mg/mL, hydrocortisone 10 mg/mL

Manufacturer

Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0851

Product ID 0713-0851_44ea2018-99d5-8f97-e063-6294a90ab0f2

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA218273

Listing Expiration 2026-12-31

Marketing Start 2025-12-04

Pharmacologic Class

Established (EPC)

corticosteroid [epc]

Mechanism of Action

corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130851

Hyphenated Format 0713-0851

Supplemental Identifiers

RxCUI

309305

UNII

4BA73M5E37 WI4X0X7BPJ

NUI

N0000175576 N0000175450

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ciprofloxacin hydrochloride and hydrocortisone (source: ndc)

Generic Name ciprofloxacin hydrochloride and hydrocortisone (source: ndc)

Application Number ANDA218273 (source: ndc)

Routes

AURICULAR (OTIC)

source: ndc

Resolved Composition

Strengths

2 mg/mL
10 mg/mL

source: ndc

Packaging

1 BOTTLE in 1 CARTON (0713-0851-09) / 10 mL in 1 BOTTLE

source: ndc

Packages (1)

0713-0851-09 1 BOTTLE in 1 CARTON (0713-0851-09) / 10 mL in 1 BOTTLE

Ingredients (2)

ciprofloxacin hydrochloride (2 mg/mL) hydrocortisone (10 mg/mL)

Linked Drug Pages (1)

ciprofloxacin hydrochloride and hydrocortisone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["AURICULAR (OTIC)"], "spl_id": "44ea2018-99d5-8f97-e063-6294a90ab0f2", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["4BA73M5E37", "WI4X0X7BPJ"], "rxcui": ["309305"], "spl_set_id": ["6848cb55-7ca4-40ca-9751-f1fc262b8336"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0713-0851-09)  / 10 mL in 1 BOTTLE", "package_ndc": "0713-0851-09", "marketing_start_date": "20251204"}], "brand_name": "ciprofloxacin hydrochloride and hydrocortisone", "product_id": "0713-0851_44ea2018-99d5-8f97-e063-6294a90ab0f2", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Cytochrome P450 1A2 Inhibitors [MoA]", "Fluoroquinolone Antibacterial [EPC]", "Fluoroquinolones [CS]"], "product_ndc": "0713-0851", "generic_name": "ciprofloxacin hydrochloride and hydrocortisone", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ciprofloxacin hydrochloride and hydrocortisone", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "2 mg/mL"}, {"name": "HYDROCORTISONE", "strength": "10 mg/mL"}], "application_number": "ANDA218273", "marketing_category": "ANDA", "marketing_start_date": "20251204", "listing_expiration_date": "20261231"}