Naloxone Hydrochloride Spray
NDC Package 68001-645-45
Package Information
Naloxone Hydrochloride sprays is emergency Treatment of Opioid OverdoseImportant:For use in the nose onlyDo not test nasal spray device before use1 nasal spray device contains 1 dose of medicineEach device sprays 1 time onlyDo not test nasal spray device before use1 nasal spray device contains 1 dose of medicineEach device sprays 1 time onlyStep 1: CHECK if you suspect an overdose:• CHECKfor a suspected overdose: the person will not wake up or is very sleepy or not breathing well •yell “Wake up!” •shake the person gently •if the person is not awake, go to Step 2 Step 2: GIVE 1st dose in the nose• HOLDthe nasal spray device with your thumb on the bottom of the plunger • INSERTthe nozzle into either NOSTRIL • PRESSthe plunger firmly to give the 1st dose •1 nasal spray device contains 1 dose Step 3: CALL• CALL 911immediately after giving the 1st dose Step 4: WATCH & GIVE• WAIT2-3 minutes after the 1st dose to give the medicine time to work •if the person wakes up: Go to Step 5 •if the person does not wake up: • CONTINUE TO GIVEdoses every 2-3 minutes until the person wakes up •it is safe to keep giving doses Step 5: STAY• STAYuntil ambulance arrives: even if the person wakes up • GIVEanother dose if the person becomes very sleepy again •You may need to give all the doses in the pack For opioid emergencies, call 911. This formulation utilizes a spray delivery system. Marketed by Bluepoint Laboratories, this product is identified by NDC 68001-645 and is authorized under FDA application ANDA211951.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 68001 - Bluepoint Laboratories
- 68001-645 - Naloxone Hydrochloride
- 68001-645-45 - 2 VIAL, SINGLE-DOSE in 1 CARTON / .1 mL in 1 VIAL, SINGLE-DOSE
- 68001-645 - Naloxone Hydrochloride
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 68001-645-45 identifies a specific commercial package of 2 vial, single-dose in 1 carton / .1 ml in 1 vial, single-dose of Naloxone Hydrochloride, a human over the counter drug labeled by Bluepoint Laboratories. This spray is formulated for nasal use and contains naloxone hydrochloride as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Bluepoint Laboratories on May 01, 2025. The current certification is valid through December 31, 2027.
How is this Bluepoint Laboratories product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 68001064545. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
