Prescription drug · ANDA

Naltrexone Hydrochloride NDC 70518-4344

Naltrexone hydrochloride 50 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)70518-4344Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-4344Add 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 NDC11-digit (billing)PackageCopy
70518-4344-07051843440030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4344-0)Marketed from May 20, 2025

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
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075274
Marketing start
Marketing end
Other FDA classes
Opioid Antagonists (Mechanism)
Identifiers
Product ID 70518-4344_5af904a2-494c-8a8c-e063-6294a90a3b93SPL ID 5af904a2-494c-8a8c-e063-6294a90a3b93SPL set ID db911559-26f5-43a0-b61f-3425176c936fRxCUI 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

N470518434400 followed by a unit qualifier and the quantity

Package 70518-4344-00. 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 .

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 70518-4344

What is NDC 70518-4344?
70518-4344 is the product NDC for Naltrexone Hydrochloride, Naltrexone hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. 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?
REMEDYREPACK INC., NDC labeler code 70518. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralCoupler LLC67046-030667046-0306-03
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralCoupler LLC67046-006067046-0060-03
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC53401-02353401-0023-3053401-0023-3153401-0023-53
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralElite Laboratories, Inc.64850-30064850-0300-0164850-0300-30
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-301171335-3011-01
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-301271335-3012-01
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-303971335-3039-01
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-304071335-3040-01
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-252972162-2529-0172162-2529-03
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals Inc.68071-365468071-3654-03

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
ProductStrengthForm · routeLabelerProduct NDC
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralAvKARE42291-632
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralTAGI Pharma Inc.51224-206
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC53401-008
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC53401-023
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-1047
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralElite Laboratories, Inc.64850-300
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralCoupler LLC67046-0060
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals Inc.68071-3654
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralPrecision Dose Inc.68094-853
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralPrecision Dose Inc.68094-909
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2419
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2480
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2481
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2743
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2987
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3011
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3012
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3039
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3040
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3104

Showing 20 of 23.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in