Prescription drug · NDA
Numbrino (cocaine hydrochloride nasal) NDC 81665-300
Cocaine hydrochloride 40 mg/mL · Solution · Topical · OMNIVIUM PHARMACEUTICALS LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81665-300-02 | 81665030002 | 1 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
- 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
N481665030002followed by a unit qualifier and the quantityPackage 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.
Other NDCs under NDA 209575
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 |
|---|---|---|---|---|
| cocaine hydrochloride nasal | Cocaine hydrochloride 40 mg/mL | SolutionTopical | OMNIVIUM PHARMACEUTICALS LLC. | 81665-301 |