NDC codes

FDA NDC Directory
Product NDC (as listed)81665-300Labeler and product segments. Claims need a package NDC.
Product NDC at billing width81665-0300Add 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
81665-300-0281665030002816650300021 BOTTLE, GLASS in 1 CARTON (81665-300-02) / 4 mL in 1 BOTTLE, GLASSMarketed from Jun 19, 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)
Numbrino
Generic name (nonproprietary)
cocaine hydrochloride nasal
Active ingredients
Cocaine hydrochloride — 40 mg/mL
Dosage form
Solution
Route
Topical
Labeler
OMNIVIUM PHARMACEUTICALS LLC.NDC labeler code 81665
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 209575
Marketing start
Listing expires
DEA schedule
CII
Identifiers
Product ID 81665-300_b722df62-ac8d-49c0-b357-c814b89471feSPL ID b722df62-ac8d-49c0-b357-c814b89471feSPL set ID d724b5b4-6654-4bf5-9eed-e2c7943084edRxCUI 1995288, 2272608UNII XH8T8T6WZHUPC 0381665300026

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

N481665030002 followed by a unit qualifier and the quantity

Package 81665-0300-02. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

NUMBRINO (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. NUMBRINO (cocaine hydrochloride) nasal solution is an ester local anesthetic indicated for the introduction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 81665-300

What is NDC 81665-300?
81665-300 is the product NDC for Numbrino (cocaine hydrochloride nasal), Cocaine hydrochloride 40 mg/mL solution, listed with the FDA by OMNIVIUM PHARMACEUTICALS LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Numbrino (Cocaine hydrochloride nasal).
What is the active ingredient?
Cocaine hydrochloride.
Who is the labeler?
OMNIVIUM PHARMACEUTICALS LLC., NDC labeler code 81665. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Numbrino?
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.

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
ProductStrengthForm · routeLabelerProduct NDC
cocaine hydrochloride nasalCocaine hydrochloride 40 mg/mLSolutionTopicalOMNIVIUM PHARMACEUTICALS LLC.81665-301

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