Prescription drug · NDA
Zimhi (Naloxone hydrochloride) NDC 84571-140
Naloxone hydrochloride 5 mg/.5mL · Injection, Solution · Intramuscular, Subcutaneous · ZMI Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84571-140-02 | 8457101400284571014002 | 2 CASE in 1 CARTON (84571-140-02) / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGEMarketed from Jan 15, 2022 | |
| 84571-140-11 | 8457101401184571014011 | 1 CASE in 1 CARTON (84571-140-11) / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGEMarketed from Jan 15, 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)
- Zimhi
- Generic name (nonproprietary)
- naloxone hydrochloride
- Active ingredients
- Naloxone hydrochloride — 5 mg/.5mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Subcutaneous
- Labeler
- ZMI Pharma Inc.NDC labeler code 84571
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212854
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 84571-140_4525b96b-5ab9-b8fd-e063-6294a90aa699SPL ID 4525b96b-5ab9-b8fd-e063-6294a90aa699SPL set ID 523c0909-bff6-4010-988a-53de18b7cb3fRxCUI 2589612, 2589618UNII F850569PQR
- 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
N484571014002followed by a unit qualifier and the quantityPackage 84571-0140-02. 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)
1. INDICATIONS AND USAGE ZIMHI is indicated in adults and pediatric patients for: the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. ZIMHI is intended for immediate administration as emergency therapy in settings where opioids may be present. ZIMHI is not a substitute for emergency medical care. ZIMHI is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. ( 1 ) ZIMHI is intended for immediate administration as emergency therapy in settings where opioids may be present. ( 1 ) ZIMHI is not a subst…
Excerpt only. Read the full label for complete information.
About NDC 84571-140
- What is NDC 84571-140?
- 84571-140 is the product NDC for Zimhi (naloxone hydrochloride), Naloxone hydrochloride 5 mg/.5mL injection, solution, listed with the FDA by ZMI Pharma Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zimhi (Naloxone Hydrochloride).
- What is the active ingredient?
- Naloxone hydrochloride.
- Who is the labeler?
- ZMI Pharma Inc., NDC labeler code 84571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zimhi?
- 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.