What is NDC 53401-023?

53401-023 is the product NDC for Naltrexone Hydrochloride, Naltrexone hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 53401. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Naltrexone Hydrochloride?

44 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Naltrexone Hydrochloride NDC 53401-023

NDC codes

FDA NDC Directory

Product NDC (as listed)53401-023Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53401-0023Add 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
53401-023-30	53401002330	30 TABLET, FILM COATED in 1 BOTTLE (53401-023-30)Marketed from Jul 28, 2026
53401-023-31	53401002331	600 TABLET, FILM COATED in 1 BOTTLE (53401-023-31)Marketed from Sep 17, 2026
53401-023-53	53401002353	60 TABLET, FILM COATED in 1 BOTTLE (53401-023-53)Marketed from Jul 28, 2026

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): Naltrexone Hydrochloride
Generic name (nonproprietary): naltrexone hydrochloride
Active ingredients: Naltrexone hydrochloride — 50 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 53401
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075274
Marketing start: Aug 15, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Opioid Antagonists (Mechanism)
Identifiers: Product ID 53401-023_5bff1349-cf77-e098-e063-6394a90aea84SPL ID 5bff1349-cf77-e098-e063-6394a90aea84
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N453401002330 followed by a unit qualifier and the quantity

Package 53401-0023-30. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 53401-023

What is NDC 53401-023?: 53401-023 is the product NDC for Naltrexone Hydrochloride, Naltrexone hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Naltrexone Hydrochloride.
What is the active ingredient?: Naltrexone hydrochloride.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 53401. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Naltrexone Hydrochloride?: 44 other product NDCs are listed under this name. See all Naltrexone 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 Naltrexone Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0306	67046-0306-03
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0060	67046-0060-03
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Elite Laboratories, Inc.	64850-300	64850-0300-0164850-0300-30
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-3011	71335-3011-01
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-3012	71335-3012-01
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-3039	71335-3039-01
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-3040	71335-3040-01
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2529	72162-2529-0172162-2529-03
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4344	70518-4344-00
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals Inc.	68071-3654	68071-3654-03

All 45 Naltrexone Hydrochloride NDCs

Other NDCs under ANDA 075274

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

FDA NDC Directory listings under ANDA 075274
Product	Strength	Form · route	Labeler	Product NDC
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	AvKARE	42291-632
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	TAGI Pharma Inc.	51224-206
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	53401-008
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-1047
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Elite Laboratories, Inc.	64850-300
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0060
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals Inc.	68071-3654
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Precision Dose Inc.	68094-853
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Precision Dose Inc.	68094-909
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4344
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2419
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2480
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2481
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2743
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2987
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-3011
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-3012
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-3039
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-3040
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-3104

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