Prescription drug · ANDA

Naloxone Hydrochloride NDC 50090-6710

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

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-6710Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-6710Add 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
50090-6710-050090671000500906710002 VIAL, SINGLE-DOSE in 1 CARTON (50090-6710-0) / .1 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 28, 2023

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
A-S Medication SolutionsNDC labeler code 50090
Product type
Prescription 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 50090-6710_9415145a-f0c8-452d-8c56-750a184df984SPL ID 9415145a-f0c8-452d-8c56-750a184df984SPL set ID 0b3b5214-6f91-4bba-82d6-d57b16845df5RxCUI 1725059UNII F850569PQRUPC 0345802811004
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

N450090671000 followed by a unit qualifier and the quantity

Package 50090-6710-00. 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. Limitations of Use: Restrict prescription of naloxone hydrochloride nasal spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts. Naloxone HCl Nasal Spray is an opioid antagonis…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50090-6710

What is NDC 50090-6710?
50090-6710 is the product NDC for Naloxone Hydrochloride, Naloxone hydrochloride 4 mg/.1mL spray, 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.
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 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 Solutions50090-6963
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
Naloxone HydrochlorideNaloxone hydrochloride 4 mg/.1mLSprayNasalAdvanced Rx of Tennessee, LLC80425-0409

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