Over-the-counter drug · ANDA

Naloxone Hydrochloride NDC 0591-3871

Naloxone hydrochloride 4 mg/.1mL · Spray, Metered · Nasal · Actavis Pharma, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)0591-3871Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00591-3871Add 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
0591-3871-9900591387199005913871992 BLISTER PACK in 1 CARTON (0591-3871-99) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0591-3871-54) / .1 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 17, 2025

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/.1mL
Dosage form
Spray, Metered
Route
Nasal
Labeler
Actavis Pharma, Inc.NDC labeler code 0591
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209522
Marketing start
Listing expires
Other FDA classes
Opioid Antagonists (Mechanism)
Identifiers
Product ID 0591-3871_2c4bb622-fc96-4877-92c8-a15be1636137SPL ID 2c4bb622-fc96-4877-92c8-a15be1636137SPL set ID 49350f7e-d613-40a8-8941-a2ec30eafdf3RxCUI 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

N400591387199 followed by a unit qualifier and the quantity

Package 00591-3871-99. 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 0591-3871

What is NDC 0591-3871?
0591-3871 is the product NDC for Naloxone Hydrochloride, Naloxone hydrochloride 4 mg/.1mL spray, metered, listed with the FDA by Actavis Pharma, Inc.. 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?
Actavis Pharma, Inc., NDC labeler code 0591. 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 1 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousPar Health USA, LLC42023-22442023-0224-01
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSpray, MeteredNasalSportpharm LLC85766-22885766-0228-02

All 79 Naloxone Hydrochloride NDCs

Other NDCs under ANDA 209522

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

FDA NDC Directory listings under ANDA 209522
ProductStrengthForm · routeLabelerProduct NDC
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSpray, MeteredNasalTeva Pharmaceuticals, Inc.0480-3478
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSpray, MeteredNasalAsclemed USA, Inc.76420-867
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSpray, MeteredNasalSportpharm LLC85766-228

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