Over-the-counter drug · ANDA
Naloxone Hydrochloride (Naloxone) NDC 60219-2104
Naloxone hydrochloride 4 mg/.1mL · Spray · Nasal · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60219-2104-7 | 60219210407 | 2 VIAL in 1 CARTON (60219-2104-7) / .1 mL in 1 VIAL (60219-2104-1)Marketed from Apr 24, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Active ingredients
- Naloxone hydrochloride — 4 mg/.1mL
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- Amneal Pharmaceuticals NY LLCNDC labeler code 60219
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217992
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 60219-2104_a79738c5-1989-43c7-856b-f284c654c9c0SPL ID a79738c5-1989-43c7-856b-f284c654c9c0SPL set ID 8779a073-dc6e-410a-9959-fd370f0079f9RxCUI 1725059UNII F850569PQRUPC 0360219210479
- 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 HCPCS code in Med-Code's directory. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N460219210407followed by a unit qualifier and the quantityPackage 60219-2104-07. 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)
Use(s) to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin this medicine can save a life
Excerpt only. Read the full label for complete information.
About NDC 60219-2104
- What is NDC 60219-2104?
- 60219-2104 is the product NDC for Naloxone Hydrochloride (naloxone), Naloxone hydrochloride 4 mg/.1mL spray, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naloxone Hydrochloride (Naloxone).
- What is the active ingredient?
- Naloxone hydrochloride.
- Who is the labeler?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 60219. 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?
- 77 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 | 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 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | Spray, MeteredNasal | Teva Pharmaceuticals, Inc. | 0480-3478 | 00480-3478-68 |
Other NDCs under ANDA 217992
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/.1mL | SprayNasal | Walgreen Co. | 0363-2140 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | AvKARE | 42291-493 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | CVS Pharmacy, Inc | 51316-210 |
| Naloxone Hydrochloride | Naloxone hydrochloride 4 mg/.1mL | SprayNasal | Amneal Pharmaceuticals LLC | 69238-2104 |