What is NDC 76329-3369?

76329-3369 is the product NDC for Naloxone Hydrochloride, Naloxone hydrochloride 1 mg/mL injection, listed with the FDA by International Medication Systems, Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

International Medication Systems, Limited, NDC labeler code 76329. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Naloxone Hydrochloride NDC 76329-3369

NDC codes

FDA NDC Directory

Product NDC (as listed)76329-3369Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76329-3369Add 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
76329-3369-1	7632933690176329336901	10 SYRINGE in 1 BOX (76329-3369-1) / 2 mL in 1 SYRINGEMarketed from Jun 1, 2001

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 — 1 mg/mL
Dosage form: Injection
Route: Parenteral
Labeler: International Medication Systems, LimitedNDC labeler code 76329
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 072076
Marketing start: Jun 1, 2001
Listing expires: Dec 31, 2026
Other FDA classes: Opioid Antagonists (Mechanism)
Identifiers: Product ID 76329-3369_2db33194-380a-4dd5-ba87-abdad14209bdSPL ID 2db33194-380a-4dd5-ba87-abdad14209bdSPL set ID 236349ef-2cb5-47ca-a3a5-99534c3a4996RxCUI 1191250UNII 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.

NDC on a medical claim

N476329336901 followed by a unit qualifier and the quantity

Package 76329-3369-01. 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 Dec 16, 2024.

Indications (excerpt from the label)

INDICATIONS AND 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 and butorphanol and cyclazocine. Naloxone hydrochloride is also indicated for the 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 76329-3369

What is NDC 76329-3369?: 76329-3369 is the product NDC for Naloxone Hydrochloride, Naloxone hydrochloride 1 mg/mL injection, listed with the FDA by International Medication Systems, Limited. 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?: International Medication Systems, Limited, NDC labeler code 76329. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
naloxone hydrochloride	Naloxone hydrochloride .4 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	REMEDYREPACK INC.	70518-4785	70518-4785-00
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

All 79 Naloxone Hydrochloride NDCs

Other NDCs under ANDA 072076

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

FDA NDC Directory listings under ANDA 072076
Product	Strength	Form · route	Labeler	Product NDC
Naloxone Hydrochloride	Naloxone hydrochloride 1 mg/mL	InjectionParenteral	Henry Schein, Inc	0404-9922
Naloxone Hydrochloride	Naloxone hydrochloride 1 mg/mL	InjectionParenteral	HF Acquisition Co. LLC, DBA HealthFirst	51662-1239
Naloxone Hydrochloride	Naloxone hydrochloride 1 mg/mL	InjectionParenteral	REMEDYREPACK INC.	70518-2725
Naloxone Hydrochloride	Naloxone hydrochloride 1 mg/mL	InjectionParenteral	Medical Purchasing Solutions, LLC	71872-7177
Naloxone Hydrochloride	Naloxone hydrochloride 1 mg/mL	InjectionParenteral	Medical Purchasing Solutions, LLC	71872-7294
Naloxone Hydrochloride	Naloxone hydrochloride 1 mg/mL	InjectionParenteral	International Medication Systems, Limited	76329-1469
Naloxone Hydrochloride	Naloxone hydrochloride 1 mg/mL	InjectionParenteral	International Medication Systems, Limited	76329-3469