Prescription drug · ANDA
Ciprofloxacin and dexamethasone NDC 67296-1943
Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL · Suspension/ drops · Auricular (Otic) · Redpharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-1943-8 | 6729619430867296194308 | 1 BOTTLE, DROPPER in 1 CARTON (67296-1943-8) / 8 mL in 1 BOTTLE, DROPPERMarketed from Nov 1, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ciprofloxacin and dexamethasone
- Generic name (nonproprietary)
- ciprofloxacin and dexamethasone
- Active ingredients
- Ciprofloxacin hydrochloride — 3 mg/mLDexamethasone — 1 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Auricular (Otic)
- Labeler
- Redpharm DrugNDC labeler code 67296
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215768
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 67296-1943_46e9281b-8358-5642-e063-6394a90a4ae8SPL ID 46e9281b-8358-5642-e063-6394a90a4ae8SPL set ID 2fd20fcb-222c-bd38-e063-6294a90ac9cdRxCUI 403908UNII 4BA73M5E37, 7S5I7G3JQL
- Pharmacologic class
- Corticosteroid; Fluoroquinolone Antibacterial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N467296194308followed by a unit qualifier and the quantityPackage 67296-1943-08. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension USP is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa . Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Acute Otitis Externa (AOE) i…
Excerpt only. Read the full label for complete information.
About NDC 67296-1943
- What is NDC 67296-1943?
- 67296-1943 is the product NDC for Ciprofloxacin and dexamethasone, Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL suspension/ drops, listed with the FDA by Redpharm Drug. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ciprofloxacin and dexamethasone.
- What is the active ingredient?
- Ciprofloxacin hydrochloride, Dexamethasone.
- Who is the labeler?
- Redpharm Drug, NDC labeler code 67296. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ciprofloxacin and dexamethasone?
- 12 other product NDCs are listed under this name. See all Ciprofloxacin and dexamethasone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ciprofloxacin and dexamethasone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ciprofloxacin and dexamethasone | Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsAuricular (Otic) | Sentiss Pharmaceuticals LLC | 70244-033 | 70244-0033-01 |
| Ciprofloxacin and Dexamethasoneciprofloxacin hydrochloride and dexamethasone | Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL | SuspensionAuricular (Otic) | Upsher-Smith Laboratories, LLC | 0832-1430 | 00832-1430-75 |
| Ciprofloxacin and Dexamethasone | Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsAuricular (Otic) | Amneal Pharmaceuticals of New York LLC | 53746-831 | 53746-0831-53 |
| Ciprofloxacin and dexamethasone | Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsAuricular (Otic) | ARMAS PHARMACEUTICALS INC. | 72485-625 | 72485-0625-13 |
| Ciprofloxacin and dexamethasone | Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsAuricular (Otic) | Sun Pharmaceutical Industries, Inc. | 62756-427 | 62756-0427-90 |
| Ciprofloxacin and dexamethasone | Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsAuricular (Otic) | NuCare Pharmaceutical, Inc. | 68071-3977 | 68071-3977-07 |
| Ciprofloxacin and Dexamethasone | Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsAuricular (Otic) | NorthStar RxLLC | 16714-628 | 16714-0628-01 |
| Ciprofloxacin and Dexamethasone | Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsAuricular (Otic) | Redpharm Drug | 67296-2257 | 67296-2257-08 |
| Ciprofloxacin and Dexamethasone | Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsAuricular (Otic) | Sandoz Inc | 0781-6186 | 00781-6186-67 |
| Ciprofloxacin and Dexamethasone | Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsAuricular (Otic) | Dr. Reddy's Laboratories, Inc. | 43598-326 | 43598-0326-75 |
Other NDCs under ANDA 215768
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ciprofloxacin and dexamethasone | Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsAuricular (Otic) | Sentiss Pharmaceuticals LLC | 70244-033 |
| Ciprofloxacin and dexamethasone | Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsAuricular (Otic) | ARMAS PHARMACEUTICALS INC. | 72485-625 |