Prescription drug · NDA AUTHORIZED GENERIC

Naloxone Hydrochloride (Naloxone hydrochloride nasal) NDC 50090-5908

Naloxone hydrochloride 4 mg/.1mL · Inhalant · Nasal · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-5908Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-5908Add 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
50090-5908-050090590800500905908002 VIAL, SINGLE-DOSE in 1 CARTON (50090-5908-0) / .1 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 19, 2022

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 nasal
Active ingredients
Naloxone hydrochloride — 4 mg/.1mL
Dosage form
Inhalant
Route
Nasal
Labeler
A-S Medication SolutionsNDC labeler code 50090
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 208411
Marketing start
Listing expires
Other FDA classes
Opioid Antagonists (Mechanism)
Identifiers
Product ID 50090-5908_fefa320d-95d8-414e-ad54-40c9f6d2c55dSPL ID fefa320d-95d8-414e-ad54-40c9f6d2c55dSPL set ID 4517afa1-4b17-4a15-b91b-65b18bd0558fRxCUI 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

N450090590800 followed by a unit qualifier and the quantity

Package 50090-5908-00. 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)

Naloxone HCl Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Naloxone HCl Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. Naloxone HCl Nasal Spray is not a substitute for emergency medical care. Naloxone HCl Nasal Spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. ( 1 ) Naloxone HCl Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50090-5908

What is NDC 50090-5908?
50090-5908 is the product NDC for Naloxone Hydrochloride (naloxone hydrochloride nasal), Naloxone hydrochloride 4 mg/.1mL inhalant, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Naloxone Hydrochloride (Naloxone Hydrochloride Nasal).
What is the active ingredient?
Naloxone hydrochloride.
Who is the labeler?
A-S Medication Solutions, NDC labeler code 50090. 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 NDA 208411

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

FDA NDC Directory listings under NDA 208411
ProductStrengthForm · routeLabelerProduct NDC
Narcannaloxone hydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalA-S Medication Solutions50090-2422
Narcannaloxone hydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalEmergent Devices Inc.69547-353
Narcannaloxone hydrochloride nasalNaloxone hydrochloride 4 mg/.1mLSprayNasalEmergent Devices Inc.69547-627
Narcannaloxone hydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalProficient Rx LP71205-528
Narcannaloxone hydrochloride nasalNaloxone hydrochloride 4 mg/.1mLSprayNasalSportpharm LLC85766-076
Narcan Naloxone HciNaloxone hydrochloride 4 mg/.1mLSprayNasalHF Acquisition Co LLC, DBA HealthFirst51662-1240
Narcan Naloxone HCLNaloxone hydrochloride 4 mg/.1mLSprayNasalHF Acquisition Co LLC, DBA HealthFirst51662-1642

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