What is NDC 76045-112?

76045-112 is the product NDC for Naloxone Hydrochloride, Naloxone hydrochloride 1 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 76045. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Naloxone Hydrochloride NDC 76045-112 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76045-112Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76045-0112Add 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 NDC	11-digit (billing)	Package	Copy
76045-112-20	76045011220	24 SYRINGE in 1 CASE (76045-112-20) / 2 mL in 1 SYRINGE (76045-112-01)Marketed from Apr 2, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 1 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular, Intravenous, Subcutaneous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 76045
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213573
Marketing start: Apr 2, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Opioid Antagonists (Mechanism)
Identifiers: Product ID 76045-112_6503f42d-3303-497a-9653-4b6d89bf7833SPL ID 6503f42d-3303-497a-9653-4b6d89bf7833SPL set ID 201fdedf-1736-4e52-9d7d-de14292547fdRxCUI 1191250, 2679504UNII 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 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

N476045011220 followed by a unit qualifier and the quantity

Package 76045-0112-20. 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 Jul 31, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Naloxone 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 is also indicated for diagnosis of suspected or known acute opioid overdosage. Naloxone 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 76045-112

What is NDC 76045-112?: 76045-112 is the product NDC for Naloxone Hydrochloride, Naloxone hydrochloride 1 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, 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?: Fresenius Kabi USA, LLC, NDC labeler code 76045. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
naloxone hydrochloride	Naloxone hydrochloride .4 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Lifestar Pharma LLC	70756-850	70756-0850-1070756-0850-2570756-0850-82
Naloxone Hydrochloride	Naloxone hydrochloride .4 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Henry Schein, Inc.	0404-9773	00404-9773-01
Naloxone Hydrochloride	Naloxone hydrochloride .4 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6193	00641-6193-10
naloxone hydrochloride	Naloxone hydrochloride 1 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Baxter Healthcare Corporation	43066-142	43066-0142-10
Naloxone Hydrochloride	Naloxone hydrochloride 4 mg/.1mL	SprayNasal	BluePoint Laboratories	68001-645	68001-0645-45
Naloxone Hydrochloride	Naloxone hydrochloride 4 mg/.1mL	SprayNasal	Strategic Sourcing Services LLC	70677-1283	70677-1283-01
Naloxone Hydrochloride	Naloxone hydrochloride 4 mg/.1mL	SprayNasal	AMERISOURCE BERGEN	46122-812	46122-0812-71
Naloxone Hydrochloride	Naloxone hydrochloride 4 mg/.1mL	Spray, MeteredNasal	Actavis Pharma, Inc.	0591-3871	00591-3871-99
Naloxone Hydrochloride	Naloxone hydrochloride 1 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Par Health USA, LLC	42023-224	42023-0224-01
Naloxone Hydrochloride	Naloxone hydrochloride 4 mg/.1mL	Spray, MeteredNasal	Teva Pharmaceuticals, Inc.	0480-3478	00480-3478-68

All 78 Naloxone Hydrochloride NDCs

Other NDCs under ANDA 213573

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

FDA NDC Directory listings under ANDA 213573
Product	Strength	Form · route	Labeler	Product NDC
Naloxone Hydrochloride	Naloxone hydrochloride .4 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Fresenius Kabi USA, LLC	76045-114