Prescription drug · ANDA
nalmefene hydrochloride (Nalmefene hydrochloride injection) NDC 82432-102
Nalmefene hydrochloride 2 mg/2mL · Solution · Intramuscular, Intravenous, Subcutaneous · Chengdu Shuode Pharmaceutical Co., Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82432-102-02 | 82432010202 | 1 VIAL, GLASS in 1 CARTON (82432-102-02) / 2 mL in 1 VIAL, GLASSMarketed from Nov 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)
- nalmefene hydrochloride
- Generic name (nonproprietary)
- nalmefene hydrochloride injection
- Active ingredients
- Nalmefene hydrochloride — 2 mg/2mL
- Dosage form
- Solution
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- Chengdu Shuode Pharmaceutical Co., LtdNDC labeler code 82432
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216007
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 82432-102_52b8bd13-33cb-4def-a172-8853a39fe4c4SPL ID 52b8bd13-33cb-4def-a172-8853a39fe4c4SPL set ID 22d67228-6c24-47ca-afc7-52ef279520a0RxCUI 2592953, 2672926UNII K7K69QC05XUPC 6950425900789
- 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
N482432010202followed by a unit qualifier and the quantityPackage 82432-0102-02. 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 .
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 82432-102
- What is NDC 82432-102?
- 82432-102 is the product NDC for nalmefene hydrochloride (nalmefene hydrochloride injection), Nalmefene hydrochloride 2 mg/2mL solution, listed with the FDA by Chengdu Shuode Pharmaceutical Co., Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- nalmefene hydrochloride (Nalmefene hydrochloride injection).
- What is the active ingredient?
- Nalmefene hydrochloride.
- Who is the labeler?
- Chengdu Shuode Pharmaceutical Co., Ltd, NDC labeler code 82432. 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 Hydrochloride | Nalmefene hydrochloride 1 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Knoa Pharma LLC | 59011-960 | 59011-0960-10 |
Other NDCs under ANDA 216007
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 |
|---|---|---|---|---|
| nalmefene hydrochloridenalmefene hydrochloride injection | Nalmefene hydrochloride .1 mg/mL | SolutionIntramuscular, Intravenous, Subcutaneous | Chengdu Shuode Pharmaceutical Co., Ltd | 82432-101 |