NDC codes

FDA NDC Directory
Product NDC (as listed)64950-381Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64950-0381Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
64950-381-14649500381146495003811414 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

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

N464950038114 followed by a unit qualifier and the quantity

Package 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.

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