ciprofloxacin and dexamethasone

Generic: ciprofloxacin and dexamethasone

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

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

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3804
Product ID 68071-3804_2f780394-c54f-9d92-e063-6294a90ab37b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205548
Listing Expiration 2026-12-31
Marketing Start 2020-08-10

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 680713804
Hyphenated Format 68071-3804

Supplemental Identifiers

RxCUI
403908
UPC
0368071380477
UNII
4BA73M5E37 7S5I7G3JQL
NUI
N0000175576 N0000175450

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 ANDA205548 (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 (68071-3804-7) / 7.5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

68071-3804-7 1 BOTTLE, DROPPER in 1 CARTON (68071-3804-7) / 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": "2f780394-c54f-9d92-e063-6294a90ab37b", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0368071380477"], "unii": ["4BA73M5E37", "7S5I7G3JQL"], "rxcui": ["403908"], "spl_set_id": ["2f780550-ecbf-98fc-e063-6294a90a11c0"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (68071-3804-7)  / 7.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "68071-3804-7", "marketing_start_date": "20250303"}], "brand_name": "Ciprofloxacin and Dexamethasone", "product_id": "68071-3804_2f780394-c54f-9d92-e063-6294a90ab37b", "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": "68071-3804", "generic_name": "Ciprofloxacin and Dexamethasone", "labeler_name": "NuCare Pharmaceuticals, 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": "ANDA205548", "marketing_category": "ANDA", "marketing_start_date": "20200810", "listing_expiration_date": "20261231"}