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NDC 00078-0799-75 CIPRODEX 3; 1 mg/mL; mg/mL Details
CIPRODEX 3; 1 mg/mL; mg/mL
CIPRODEX is a AURICULAR (OTIC) SUSPENSION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. 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: 00078-0799-75Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ciprofloxacin and Dexamethasone Otic
Product Information
| NDC | 00078-0799 |
|---|---|
| Product ID | 0078-0799_ccd4ff25-82eb-44ec-9b4b-0a9cef26cecc |
| 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 | Brand |
| Proprietary Name | CIPRODEX |
| 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 | Novartis Pharmaceuticals Corporation |
| 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 |
| Application Number | NDA021537 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00078-0799-75 (00078079975)
| NDC Package Code | 0078-0799-75 |
|---|---|
| Billing NDC | 00078079975 |
| Package | 1 BOTTLE in 1 CARTON (0078-0799-75) / 7.5 mL in 1 BOTTLE |
| Marketing Start Date | 2020-07-28 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 31.8548 |
| Pricing Unit | ML |
| Effective Date | 2023-08-23 |
| NDC Description | CIPRODEX OTIC SUSPENSION |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
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