ciprofloxacin and dexamethasone

Generic: ciprofloxacin and dexamethasone

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin and dexamethasone
Generic Name ciprofloxacin and dexamethasone
Labeler sun pharmaceutical industries, inc.
Dosage Form SUSPENSION/ DROPS
Routes
AURICULAR (OTIC)
Active Ingredients

ciprofloxacin hydrochloride 3 mg/mL, dexamethasone 1 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-427
Product ID 62756-427_0ef8a636-e2f1-44b7-9a8e-f2da62fbd084
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210470
Listing Expiration 2026-12-31
Marketing Start 2022-09-01

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 62756427
Hyphenated Format 62756-427

Supplemental Identifiers

RxCUI
403908
UPC
0362756427907
UNII
4BA73M5E37 7S5I7G3JQL
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 and dexamethasone (source: ndc)
Generic Name ciprofloxacin and dexamethasone (source: ndc)
Application Number ANDA210470 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (62756-427-90) / 7.5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

62756-427-90 1 BOTTLE, DROPPER in 1 CARTON (62756-427-90) / 7.5 mL in 1 BOTTLE, DROPPER

Ingredients (2)

ciprofloxacin hydrochloride (3 mg/mL) dexamethasone (1 mg/mL)

Linked Drug Pages (1)

Ciprofloxacin and dexamethasone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "0ef8a636-e2f1-44b7-9a8e-f2da62fbd084", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0362756427907"], "unii": ["4BA73M5E37", "7S5I7G3JQL"], "rxcui": ["403908"], "spl_set_id": ["641bad60-9b9e-43ea-936e-5c38f27835b2"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (62756-427-90)  / 7.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "62756-427-90", "marketing_start_date": "20220901"}], "brand_name": "Ciprofloxacin and dexamethasone", "product_id": "62756-427_0ef8a636-e2f1-44b7-9a8e-f2da62fbd084", "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": "62756-427", "generic_name": "Ciprofloxacin and dexamethasone", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ciprofloxacin and dexamethasone", "active_ingredients": [{"name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "3 mg/mL"}, {"name": "DEXAMETHASONE", "strength": "1 mg/mL"}], "application_number": "ANDA210470", "marketing_category": "ANDA", "marketing_start_date": "20220901", "listing_expiration_date": "20261231"}