Prescription drug · ANDA
Naloxone Hydrochloride (Nalxone hydrochloride) NDC 72572-450
Naloxone hydrochloride .4 mg/mL · Injection · Intramuscular, Intravenous, Subcutaneous · Civica, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72572-450-25 | 7257204502572572045025 | 25 VIAL in 1 CARTON (72572-450-25) / 1 mL in 1 VIAL (72572-450-01)Marketed from Nov 11, 2019 |
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)
- Naloxone Hydrochloride
- Generic name (nonproprietary)
- nalxone hydrochloride
- Active ingredients
- Naloxone hydrochloride — .4 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- Civica, Inc.NDC labeler code 72572
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070299
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 72572-450_8d5154a2-b3a7-4f1c-9ac8-af8c21f21e96SPL ID 8d5154a2-b3a7-4f1c-9ac8-af8c21f21e96SPL set ID 21d20dff-6efe-481e-a5a0-9c80ded73ca9RxCUI 1191222UNII 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
N472572045025followed by a unit qualifier and the quantityPackage 72572-0450-25. 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, USP 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 Injection, USP is also indicated for diagnosis of suspected or known acute opioid overdosage. Naloxone Hydrochloride Injection, USP 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.
About NDC 72572-450
- What is NDC 72572-450?
- 72572-450 is the product NDC for Naloxone Hydrochloride (nalxone hydrochloride), Naloxone hydrochloride .4 mg/mL injection, listed with the FDA by Civica, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naloxone Hydrochloride (Nalxone Hydrochloride).
- What is the active ingredient?
- Naloxone hydrochloride.
- Who is the labeler?
- Civica, Inc., NDC labeler code 72572. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Naloxone Hydrochloride?
- 78 other product NDCs are listed under this name. See all Naloxone Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Naloxone 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) |
|---|---|---|---|---|---|
| naloxone hydrochloride | Naloxone hydrochloride .4 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | REMEDYREPACK INC. | 70518-4785 | 70518-4785-00 |
| naloxone hydrochloride | Naloxone hydrochloride .4 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Lifestar Pharma LLC | 70756-850 | 70756-0850-1070756-0850-2570756-0850-82 |
| Naloxone Hydrochloride | Naloxone hydrochloride .4 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Henry Schein, Inc. | 0404-9773 | 00404-9773-01 |
| Naloxone Hydrochloride | Naloxone hydrochloride .4 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0641-6193 | 00641-6193-10 |
| naloxone hydrochloride | Naloxone hydrochloride 1 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Baxter Healthcare Corporation | 43066-142 | 43066-0142-10 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | BluePoint Laboratories | 68001-645 | 68001-0645-45 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Strategic Sourcing Services LLC | 70677-1283 | 70677-1283-01 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | AMERISOURCE BERGEN | 46122-812 | 46122-0812-71 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | Spray, MeteredNasal | Actavis Pharma, Inc. | 0591-3871 | 00591-3871-99 |
| Naloxone Hydrochloride | Naloxone hydrochloride 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Par Health USA, LLC | 42023-224 | 42023-0224-01 |
Other NDCs under ANDA 070299
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 Hydrochloridenalxone hydrochloride | Naloxone hydrochloride .4 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0641-6132 |
| Naloxone Hydrochloridenalxone hydrochloride | Naloxone hydrochloride .4 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0641-6260 |
| Naloxone Hydrochloride | Naloxone hydrochloride .4 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1671 |
| Naloxone Hydrochloridenalxone hydrochloride | Naloxone hydrochloride .4 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Medical Purchasing Solutions, LLC | 71872-7009 |