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NDC 63629-8797-01 Ciprofloxacin and Dexamethasone 3; 1 mg/mL; mg/mL Details
Ciprofloxacin and Dexamethasone 3; 1 mg/mL; mg/mL
Ciprofloxacin and Dexamethasone is a AURICULAR (OTIC) SUSPENSION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE.
MedlinePlus Drug Summary
Ciprofloxacin and dexamethasone otic is used to treat outer ear infections in adults and children and acute (suddenly occurring) middle ear infections in children with ear tubes. Ciprofloxacin is in a class of medications called quinolone antibiotics. Dexamethasone is in a class of medications called corticosteroids. The combination of ciprofloxacin and dexamethasone works by killing the bacteria that cause infection and reducing swelling in the ear.
Related Packages: 63629-8797-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ciprofloxacin and Dexamethasone Otic
Product Information
NDC | 63629-8797 |
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Product ID | 63629-8797_1fdea66b-522b-440f-acbf-3c33727a7506 |
Associated GPIs | 87991002361820 |
GCN Sequence Number | 052911 |
GCN Sequence Number Description | ciprofloxacin HCl/dexameth DROPS SUSP 0.3 %-0.1% OTIC (EAR) |
HIC3 | Q8F |
HIC3 Description | OTIC PREPARATIONS,ANTI-INFLAMMATORY-ANTIBIOTICS |
GCN | 20188 |
HICL Sequence Number | 025488 |
HICL Sequence Number Description | CIPROFLOXACIN HCL/DEXAMETHASONE |
Brand/Generic | Generic |
Proprietary Name | Ciprofloxacin and Dexamethasone |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | ciprofloxacin and dexamethasone |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | SUSPENSION/ DROPS |
Route | AURICULAR (OTIC) |
Active Ingredient Strength | 3; 1 |
Active Ingredient Units | mg/mL; mg/mL |
Substance Name | CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE |
Labeler Name | Bryant Ranch Prepack |
Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS] |
DEA Schedule | n/a |
Marketing Category | NDA AUTHORIZED GENERIC |
Application Number | NDA021537 |
Listing Certified Through | 2025-12-31 |
Package
NDC 63629-8797-01 (63629879701)
NDC Package Code | 63629-8797-1 |
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Billing NDC | 63629879701 |
Package | 1 BOTTLE, DROPPER in 1 CARTON (63629-8797-1) / 7.5 mL in 1 BOTTLE, DROPPER |
Marketing Start Date | 2021-09-10 |
NDC Exclude Flag | N |
Pricing Information | N/A |