What is NDC 71335-2481?

71335-2481 is the product NDC for Naltrexone Hydrochloride, Naltrexone hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. 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 71335-2481

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-2481Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-2481Add 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
71335-2481-1	71335248101	100 TABLET, FILM COATED in 1 BOTTLE (71335-2481-1)Marketed from Aug 27, 2024

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): Naltrexone Hydrochloride
Generic name (nonproprietary): naltrexone hydrochloride
Active ingredients: Naltrexone hydrochloride — 50 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075274
Marketing start: Feb 15, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Opioid Antagonists (Mechanism)
Identifiers: Product ID 71335-2481_0664c893-a688-4ed6-99f7-4fe40d3f8514SPL ID 0664c893-a688-4ed6-99f7-4fe40d3f8514SPL set ID 5fec6721-3611-44ec-b4b9-118472250b01RxCUI 1483744UNII Z6375YW9SF
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

N471335248101 followed by a unit qualifier and the quantity

Package 71335-2481-01. 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 Aug 27, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Naltrexone Hydrochloride Tablets USP are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone Hydrochloride Tablets USP have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2481

What is NDC 71335-2481?: 71335-2481 is the product NDC for Naltrexone Hydrochloride, Naltrexone hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, 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?: Bryant Ranch Prepack, NDC labeler code 71335. 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	Bryant Ranch Prepack	72162-2529	72162-2529-0172162-2529-03
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	Elite Laboratories, Inc.	64850-300	64850-0300-0164850-0300-30
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	Aphena Pharma Solutions - Tennessee, LLC	53401-023	53401-0023-3053401-0023-3153401-0023-53
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4344	70518-4344-00

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	Bryant Ranch Prepack	72162-1566
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	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	71335-3040
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	Aphena Pharma Solutions - Tennessee, LLC	53401-008
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	Aphena Pharma Solutions - Tennessee, LLC	53401-023
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0060
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	Bryant Ranch Prepack	71335-3104
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	Bryant Ranch Prepack	71335-2419
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2529
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	TAGI Pharma Inc.	51224-206
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4344

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