Prescription drug · ANDA
Nalmefene Hydrochloride NDC 59011-960
Nalmefene hydrochloride 1 mg/mL · Injection, Solution · Intramuscular, Intravenous, Subcutaneous · Knoa Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59011-960-10 | 59011096010 | 10 VIAL, GLASS in 1 CARTON (59011-960-10) / 2 mL in 1 VIAL, GLASSMarketed from Feb 8, 2022 |
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)
- Nalmefene Hydrochloride
- Generic name (nonproprietary)
- nalmefene hydrochloride
- Active ingredients
- Nalmefene hydrochloride — 1 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- Knoa Pharma LLCNDC labeler code 59011
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212955
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 59011-960_5c39d4d2-5cb7-4840-b695-6b162e575301SPL ID 5c39d4d2-5cb7-4840-b695-6b162e575301SPL set ID 3abfbffc-9e52-4fc6-ae92-6e0a97f4afe7RxCUI 2592953UNII K7K69QC05X
- Pharmacologic class
- Opioid Antagonist
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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N459011096010followed by a unit qualifier and the quantityPackage 59011-0960-10. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Nalmefene hydrochloride injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. Nalmefene hydrochloride injection is indicated in the management of known or suspected opioid overdose.
Excerpt only. Read the full label for complete information.
About NDC 59011-960
- What is NDC 59011-960?
- 59011-960 is the product NDC for Nalmefene Hydrochloride, Nalmefene hydrochloride 1 mg/mL injection, solution, listed with the FDA by Knoa Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nalmefene Hydrochloride.
- What is the active ingredient?
- Nalmefene hydrochloride.
- Who is the labeler?
- Knoa Pharma LLC, NDC labeler code 59011. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nalmefene Hydrochloride?
- 2 other product NDCs are listed under this name. See all Nalmefene Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nalmefene Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| nalmefene hydrochloridenalmefene hydrochloride injection | Nalmefene hydrochloride .1 mg/mL | SolutionIntramuscular, Intravenous, Subcutaneous | Chengdu Shuode Pharmaceutical Co., Ltd | 82432-101 | 82432-0101-01 |
| nalmefene hydrochloridenalmefene hydrochloride injection | Nalmefene hydrochloride 2 mg/2mL | SolutionIntramuscular, Intravenous, Subcutaneous | Chengdu Shuode Pharmaceutical Co., Ltd | 82432-102 | 82432-0102-02 |