ciprofloxacin and dexamethasone

Generic: ciprofloxacin and dexamethasone

Labeler: armas 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 armas pharmaceuticals inc.
Dosage Form SUSPENSION/ DROPS
Routes
AURICULAR (OTIC)
Active Ingredients

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

Manufacturer
ARMAS PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 72485-625
Product ID 72485-625_0a5b0305-9f16-b6a0-e063-6294a90aef9a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215768
Listing Expiration 2026-12-31
Marketing Start 2023-11-01

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 72485625
Hyphenated Format 72485-625

Supplemental Identifiers

RxCUI
403908
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 ANDA215768 (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 (72485-625-13) / 7.5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

72485-625-13 1 BOTTLE, DROPPER in 1 CARTON (72485-625-13) / 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": "0a5b0305-9f16-b6a0-e063-6294a90aef9a", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["4BA73M5E37", "7S5I7G3JQL"], "rxcui": ["403908"], "spl_set_id": ["eed6b293-6bbe-4bd3-ad9d-3849e0eb6c05"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["ARMAS PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (72485-625-13)  / 7.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "72485-625-13", "marketing_start_date": "20231101"}], "brand_name": "Ciprofloxacin and dexamethasone", "product_id": "72485-625_0a5b0305-9f16-b6a0-e063-6294a90aef9a", "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": "72485-625", "generic_name": "Ciprofloxacin and dexamethasone", "labeler_name": "ARMAS 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": "ANDA215768", "marketing_category": "ANDA", "marketing_start_date": "20231101", "listing_expiration_date": "20261231"}