Prescription drug · ANDA
Naloxone Hydrochloride NDC 0404-9920
Naloxone hydrochloride .4 mg/mL · Injection, Solution · Intramuscular, Intravenous, Subcutaneous · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9920-01 | 00404992001 | 1 BOX in 1 BAG (0404-9920-01) / 1 CARTRIDGE in 1 BOX / 1 mL in 1 CARTRIDGEMarketed from Jan 13, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Naloxone Hydrochloride
- Generic name (nonproprietary)
- naloxone hydrochloride
- Active ingredients
- Naloxone hydrochloride — .4 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- Henry Schein, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070172
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 0404-9920_60d937e9-a110-40d3-983d-f445518702a9SPL ID 60d937e9-a110-40d3-983d-f445518702a9SPL set ID d39635a4-ddb3-4d32-8211-eb84c78e9f59RxCUI 1191234UNII 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
N400404992001followed by a unit qualifier and the quantityPackage 00404-9920-01. 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 Naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone hydrochloride injection may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY: Adjunctive Use in Septic Shock ).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 070172
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 |
|---|---|---|---|---|
| Naloxone Hydrochloride | Naloxone hydrochloride .4 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Hospira, Inc. | 0409-1782 |
| Naloxone Hydrochloride | Naloxone hydrochloride .4 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | HF Acquisition Co. LLC, DBA HealthFirst | 51662-1238 |