Over-the-counter drug · ANDA

Naloxone Hydrochloride NDC 69238-2104

Naloxone hydrochloride 4 mg/.1mL · Spray · Nasal · Amneal Pharmaceuticals LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)69238-2104Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69238-2104Add 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
69238-2104-7692382104072 VIAL, SINGLE-DOSE in 1 CARTON (69238-2104-7) / .1 mL in 1 VIAL, SINGLE-DOSE (69238-2104-1)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 hydrochloride
Active ingredients
Naloxone hydrochloride — 4 mg/.1mL
Dosage form
Spray
Route
Nasal
Labeler
Amneal Pharmaceuticals LLCNDC labeler code 69238
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 69238-2104_38da0633-039b-450a-9b04-592db2238396SPL ID 38da0633-039b-450a-9b04-592db2238396SPL set ID 8091a73d-9ecd-4578-a57b-5d85a2c5a16aRxCUI 1725059UNII F850569PQRUPC 0369238210477
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

N469238210407 followed by a unit qualifier and the quantity

Package 69238-2104-07. 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.

Full label on DailyMed (opens in a new tab)

About NDC 69238-2104

What is NDC 69238-2104?
69238-2104 is the product NDC for Naloxone Hydrochloride, Naloxone hydrochloride 4 mg/.1mL spray, listed with the FDA by Amneal Pharmaceuticals 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?
Amneal Pharmaceuticals LLC, NDC labeler code 69238. 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.

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, 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
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSpray, MeteredNasalTeva Pharmaceuticals, Inc.0480-347800480-3478-68

All 78 Naloxone Hydrochloride NDCs

Other NDCs under ANDA 217992

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

FDA NDC Directory listings under ANDA 217992
ProductStrengthForm · routeLabelerProduct NDC
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalWalgreen Co.0363-2140
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalAvKARE42291-493
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalCVS Pharmacy, Inc51316-210
Naloxone HydrochloridenaloxoneNaloxone hydrochloride 4 mg/.1mLSprayNasalAmneal Pharmaceuticals NY LLC60219-2104

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