naloxone hydrochloride NDC 70756-658

NDC codes

FDA NDC Directory

Product NDC (as listed)70756-658Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70756-0658Add 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
70756-658-10	70756065810	10 VIAL, SINGLE-DOSE in 1 CARTON (70756-658-10) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 29, 2024
70756-658-25	70756065825	25 VIAL, SINGLE-DOSE in 1 CARTON (70756-658-25) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 29, 2024
70756-658-82	70756065882	1 VIAL, SINGLE-DOSE in 1 CARTON (70756-658-82) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 29, 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 — .4 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular, Intravenous, Subcutaneous
Labeler: Lifestar Pharma LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218404
Marketing start: Feb 29, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Opioid Antagonists (Mechanism)
Identifiers: Product ID 70756-658_bc5568c5-97d3-49b1-94c7-f9f3c6c9d409SPL ID bc5568c5-97d3-49b1-94c7-f9f3c6c9d409SPL set ID ef647e2a-84e7-4e3e-942a-b6fc250141b6RxCUI 1659929UNII F850569PQRUPC 0370756658825, 0370756658108, 0370756658252
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

N470756065810 followed by a unit qualifier and the quantity

Package 70756-0658-10. 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 Mar 4, 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, 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)

Other NDCs under ANDA 218404

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

FDA NDC Directory listings under ANDA 218404
Product	Strength	Form · route	Labeler	Product NDC
naloxone hydrochloride	Naloxone hydrochloride .4 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Lifestar Pharma LLC	70756-850
Naloxone Hydrochloride	Naloxone hydrochloride .4 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Henry Schein, Inc.	0404-9773
naloxone hydrochloride	Naloxone hydrochloride .4 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	NorthStar RxLLC	72603-590