Over-the-counter drug · ANDA

Naloxone Hydrochloride NDC 80425-0409

Naloxone hydrochloride 4 mg/.1mL · Spray · Nasal · Advanced Rx of Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0409Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0409Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
80425-0409-180425040901804250409012 VIAL, SINGLE-DOSE in 1 CARTON (80425-0409-1) / .1 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 27, 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 hydrochloride
Active ingredients
Naloxone hydrochloride — 4 mg/.1mL
Dosage form
Spray
Route
Nasal
Labeler
Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211951
Marketing start
Listing expires
Other FDA classes
Opioid Antagonists (Mechanism)
Identifiers
Product ID 80425-0409_1be2d8f6-f643-69a6-e063-6294a90a327fSPL ID 1be2d8f6-f643-69a6-e063-6294a90a327fSPL set ID 1be2e38b-55ca-abea-e063-6394a90ac548RxCUI 1725059UNII 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 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

N480425040901 followed by a unit qualifier and the quantity

Package 80425-0409-01. 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)

Uses • 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.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0409

What is NDC 80425-0409?
80425-0409 is the product NDC for Naloxone Hydrochloride, Naloxone hydrochloride 4 mg/.1mL spray, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Naloxone Hydrochloride.
What is the active ingredient?
Naloxone hydrochloride.
Who is the labeler?
Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Naloxone Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
naloxone hydrochlorideNaloxone hydrochloride .4 mg/mLInjection, SolutionIntramuscular, Intravenous, SubcutaneousREMEDYREPACK INC.70518-478570518-4785-00
naloxone hydrochlorideNaloxone hydrochloride .4 mg/mLInjection, SolutionIntramuscular, Intravenous, SubcutaneousLifestar Pharma LLC70756-85070756-0850-1070756-0850-2570756-0850-82
Naloxone HydrochlorideNaloxone hydrochloride .4 mg/mLInjection, SolutionIntramuscular, Intravenous, SubcutaneousHenry Schein, Inc.0404-977300404-9773-01
Naloxone HydrochlorideNaloxone hydrochloride .4 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousHikma Pharmaceuticals USA Inc.0641-619300641-6193-10
naloxone hydrochlorideNaloxone hydrochloride 1 mg/mLInjection, SolutionIntramuscular, Intravenous, SubcutaneousBaxter Healthcare Corporation43066-14243066-0142-10
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalBluePoint Laboratories68001-64568001-0645-45
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalStrategic Sourcing Services LLC70677-128370677-1283-01
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalAMERISOURCE BERGEN46122-81246122-0812-71
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSpray, MeteredNasalActavis Pharma, Inc.0591-387100591-3871-99
Naloxone HydrochlorideNaloxone hydrochloride 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousPar Health USA, LLC42023-22442023-0224-01

All 79 Naloxone Hydrochloride NDCs

Other NDCs under ANDA 211951

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 211951
ProductStrengthForm · routeLabelerProduct NDC
NALOXONE HClNaloxone hydrochloride 4 mg/.1mLSprayNasalHF Acquisition Co LLC, DBA HealthFirst51662-1620
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalPadagis Israel Pharmaceuticals Ltd45802-578
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalAMERISOURCE BERGEN46122-812
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalA-S Medication Solutions50090-6710
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalA-S Medication Solutions50090-6963
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalHF Acquisition Co LLC, DBA HealthFirst51662-1659
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalBluePoint Laboratories68001-645
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalStrategic Sourcing Services LLC70677-1283
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalProficient Rx LP71205-707
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalBryant Ranch Prepack72162-2376

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