Prescription drug · NDA
Goprelto (Cocaine hydrochloride) NDC 70839-359
Cocaine hydrochloride 40 mg/mL · Solution · Nasal · LXO US Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70839-359-04 | 70839035904 | 1 BOTTLE, GLASS in 1 CARTON (70839-359-04) / 4 mL in 1 BOTTLE, GLASSMarketed from Feb 9, 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)
- Goprelto
- Generic name (nonproprietary)
- cocaine hydrochloride
- Active ingredients
- Cocaine hydrochloride — 40 mg/mL
- Dosage form
- Solution
- Route
- Nasal
- Labeler
- LXO US Inc.NDC labeler code 70839
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209963
- Marketing start
- Listing expires
- DEA schedule
- CII
- Identifiers
- Product ID 70839-359_0f897764-fe31-090a-e063-6294a90af106SPL ID 0f897764-fe31-090a-e063-6294a90af106SPL set ID 0f897764-fe30-090a-e063-6294a90af106RxCUI 1995288, 1995293UNII XH8T8T6WZH
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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470839035904followed by a unit qualifier and the quantityPackage 70839-0359-04. 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)
GOPRELTO (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. GOPRELTO (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.
About NDC 70839-359
- What is NDC 70839-359?
- 70839-359 is the product NDC for Goprelto (cocaine hydrochloride), Cocaine hydrochloride 40 mg/mL solution, listed with the FDA by LXO US Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Goprelto (Cocaine hydrochloride).
- What is the active ingredient?
- Cocaine hydrochloride.
- Who is the labeler?
- LXO US Inc., NDC labeler code 70839. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Goprelto?
- 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 209963
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 | Cocaine hydrochloride 40 mg/mL | SolutionNasal | LXO US INC. | 70839-362 |