NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2062Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2062Add 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
71335-2062-1713352062017133520620130 TABLET, FILM COATED in 1 BOTTLE (71335-2062-1)Marketed from Mar 21, 2022
71335-2062-2713352062027133520620290 TABLET, FILM COATED in 1 BOTTLE (71335-2062-2)Marketed from Mar 21, 2022
71335-2062-3713352062037133520620360 TABLET, FILM COATED in 1 BOTTLE (71335-2062-3)Marketed from Mar 21, 2022
71335-2062-4713352062047133520620445 TABLET, FILM COATED in 1 BOTTLE (71335-2062-4)Marketed from Mar 21, 2022
71335-2062-57133520620571335206205120 TABLET, FILM COATED in 1 BOTTLE (71335-2062-5)Marketed from Mar 21, 2022
71335-2062-6713352062067133520620615 TABLET, FILM COATED in 1 BOTTLE (71335-2062-6)Marketed from Mar 21, 2022
71335-2062-77133520620771335206207100 TABLET, FILM COATED in 1 BOTTLE (71335-2062-7)Marketed from Mar 21, 2022

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 090356
Marketing start
Listing expires
Other FDA classes
Opioid Antagonists (Mechanism)
Identifiers
Product ID 71335-2062_84f6d9db-f1ef-4ddf-acdd-69e7742deefaSPL ID 84f6d9db-f1ef-4ddf-acdd-69e7742deefaSPL set ID f9807ec0-3504-4c66-8efe-ea25f84c782bRxCUI 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

N471335206201 followed by a unit qualifier and the quantity

Package 71335-2062-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Naltrexone hydrochloride tablets are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone hydrochloride has 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 71335-2062

What is NDC 71335-2062?
71335-2062 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 7 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?
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
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 coatedOralREMEDYREPACK INC.70518-434470518-4344-00

All 45 Naltrexone Hydrochloride NDCs

Other NDCs under ANDA 090356

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

FDA NDC Directory listings under ANDA 090356
ProductStrengthForm · routeLabelerProduct NDC
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8579
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7036
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.47335-326
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralCoupler LLC67046-0306
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2718
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralProficient Rx LP82804-199

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in