NDC codes

FDA NDC Directory
Product NDC (as listed)51662-1544Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51662-1544Add 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
51662-1544-1516621544011 mL in 1 VIAL, SINGLE-DOSE (51662-1544-1)Marketed from Aug 8, 2021
51662-1544-35166215440310 POUCH in 1 CASE (51662-1544-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1544-2) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Apr 22, 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
Active ingredients
Naloxone hydrochloride — .4 mg/mL
Dosage form
Injection, Solution
Route
Intramuscular, Intravenous, Subcutaneous
Labeler
HF Acquisition Co LLC, DBA HealthFirstNDC labeler code 51662
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212455
Marketing start
Listing expires
Other FDA classes
Opioid Antagonists (Mechanism)
Identifiers
Product ID 51662-1544_10352ea7-15c5-5c6c-e063-6394a90ae130SPL ID 10352ea7-15c5-5c6c-e063-6394a90ae130SPL set ID c90e2d85-ed94-2c00-e053-2a95a90ad2a0RxCUI 1659929UNII F850569PQRUPC 0355150327010
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N451662154401 followed by a unit qualifier and the quantity

Package 51662-1544-01. 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)

INDICATIONS & USAGE Naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids, including propoxyphene, methadone and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Naloxone hydrochloride injection is also indicated for diagnosis of suspected or known acute opioid overdosage. Naloxone hydrochloride injection may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY; ADJUNCTIVE USE IN SEPTIC SHOCK ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51662-1544

What is NDC 51662-1544?
51662-1544 is the product NDC for Naloxone Hydrochloride, Naloxone hydrochloride .4 mg/mL injection, solution, listed with the FDA by HF Acquisition Co LLC, DBA HealthFirst. It has 2 package NDCs, 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?
HF Acquisition Co LLC, DBA HealthFirst, NDC labeler code 51662. 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 212455

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

FDA NDC Directory listings under ANDA 212455
ProductStrengthForm · routeLabelerProduct NDC
Naloxone HydrochlorideNaloxone hydrochloride .4 mg/mLInjection, SolutionIntramuscular, Intravenous, SubcutaneousEugia US LLC55150-327
Naloxone HydrochlorideNaloxone hydrochloride .4 mg/mLInjection, SolutionIntramuscular, Intravenous, SubcutaneousMedical Purchasing Solutions, LLC71872-7219

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