cocaine hydrochloride nasal NDC 81665-301

NDC codes

FDA NDC Directory

Product NDC (as listed)81665-301Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81665-0301Add 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 NDC	11-digit (billing)	Package	Copy
81665-301-02	81665030102	1 BOTTLE, GLASS in 1 CARTON (81665-301-02) / 4 mL in 1 BOTTLE, GLASSMarketed from Oct 15, 2023

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): cocaine hydrochloride nasal
Generic name (nonproprietary): cocaine hydrochloride nasal
Active ingredients: Cocaine hydrochloride — 40 mg/mL
Dosage form: Solution
Route: Topical
Labeler: OMNIVIUM PHARMACEUTICALS LLC.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 209575
Marketing start: Oct 15, 2023
Listing expires: Dec 31, 2026
DEA schedule: CII
Identifiers: Product ID 81665-301_4aa46865-9d43-4f88-b5d3-81200c6ec945SPL ID 4aa46865-9d43-4f88-b5d3-81200c6ec945SPL set ID 4e3b2f6b-1b57-40bc-872b-01c0a3c7986eRxCUI 1995288UNII XH8T8T6WZHUPC 0381665301023

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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N481665030102 followed by a unit qualifier and the quantity

Package 81665-0301-02. 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 Sep 24, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Cocaine Hydrochloride nasal solution is indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults. Cocaine hydrochloride nasal solution is an ester local anesthetic indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 209575

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 209575
Product	Strength	Form · route	Labeler	Product NDC
Numbrinococaine hydrochloride nasal	Cocaine hydrochloride 40 mg/mL	SolutionTopical	OMNIVIUM PHARMACEUTICALS LLC.	81665-300