ciprofloxacin and dexamethasone

Generic: ciprofloxacin and dexamethasone

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ciprofloxacin and dexamethasone
Generic Name ciprofloxacin and dexamethasone
Labeler northstar rxllc
Dosage Form SUSPENSION/ DROPS
Routes
AURICULAR (OTIC)
Active Ingredients

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

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 16714-628
Product ID 16714-628_6fc9db70-e09e-2b14-8c39-98bee524acad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205548
Listing Expiration 2026-12-31
Marketing Start 2022-08-01

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 16714628
Hyphenated Format 16714-628

Supplemental Identifiers

RxCUI
403908
UPC
0316714628011
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 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 (16714-628-01) / 7.5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

16714-628-01 1 BOTTLE, DROPPER in 1 CARTON (16714-628-01) / 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": "6fc9db70-e09e-2b14-8c39-98bee524acad", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0316714628011"], "unii": ["4BA73M5E37", "7S5I7G3JQL"], "rxcui": ["403908"], "spl_set_id": ["130deaf4-ced5-abcb-2a01-205c640ddf96"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (16714-628-01)  / 7.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "16714-628-01", "marketing_start_date": "20220801"}], "brand_name": "Ciprofloxacin and Dexamethasone", "product_id": "16714-628_6fc9db70-e09e-2b14-8c39-98bee524acad", "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": "16714-628", "generic_name": "Ciprofloxacin and Dexamethasone", "labeler_name": "NorthStar RxLLC", "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": "20220801", "listing_expiration_date": "20261231"}