Prescription drug · ANDA
Ciprofloxacin Otic (Ciprofloxacin) NDC 64950-381
Ciprofloxacin .5 mg/.25mL · Solution/ drops · Auricular (Otic) · Genus Lifesciences
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64950-381-14 | 6495003811464950038114 | 14 VIAL in 1 CARTON (64950-381-14) / .25 mL in 1 VIALMarketed from Dec 1, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 Otic
- Generic name (nonproprietary)
- ciprofloxacin
- Active ingredients
- Ciprofloxacin — .5 mg/.25mL
- Dosage form
- Solution/ drops
- Route
- Auricular (Otic)
- Labeler
- Genus LifesciencesNDC labeler code 64950
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217887
- Marketing start
- Marketing end
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 64950-381_fc69400c-8758-444f-937d-ba2ac4fc95d9SPL ID fc69400c-8758-444f-937d-ba2ac4fc95d9
- Pharmacologic class
- 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
N464950038114followed by a unit qualifier and the quantityPackage 64950-0381-14. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 64950-381
- What is NDC 64950-381?
- 64950-381 is the product NDC for Ciprofloxacin Otic (ciprofloxacin), Ciprofloxacin .5 mg/.25mL solution/ drops, listed with the FDA by Genus Lifesciences. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ciprofloxacin Otic (Ciprofloxacin).
- What is the active ingredient?
- Ciprofloxacin.
- Who is the labeler?
- Genus Lifesciences, NDC labeler code 64950. 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 Otic?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.