NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0014Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0014Add 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
71335-0014-1713350014017133500140130 TABLET, FILM COATED in 1 BOTTLE (71335-0014-1)Marketed from May 14, 2026
71335-0014-2713350014027133500140290 TABLET, FILM COATED in 1 BOTTLE (71335-0014-2)Marketed from May 14, 2026
71335-0014-3713350014037133500140360 TABLET, FILM COATED in 1 BOTTLE (71335-0014-3)Marketed from May 14, 2026
71335-0014-4713350014047133500140445 TABLET, FILM COATED in 1 BOTTLE (71335-0014-4)Marketed from May 14, 2026
71335-0014-57133500140571335001405120 TABLET, FILM COATED in 1 BOTTLE (71335-0014-5)Marketed from May 14, 2026
71335-0014-6713350014067133500140615 TABLET, FILM COATED in 1 BOTTLE (71335-0014-6)Marketed from May 14, 2026
71335-0014-77133500140771335001407100 TABLET, FILM COATED in 1 BOTTLE (71335-0014-7)Marketed from May 14, 2026

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 091205
Marketing start
Listing expires
Other FDA classes
Opioid Antagonists (Mechanism)
Identifiers
Product ID 71335-0014_63e4eb6a-b262-44d1-974b-633876a9c563SPL ID 63e4eb6a-b262-44d1-974b-633876a9c563SPL set ID fa0b0881-97f3-4ca2-bc15-0954293081dbRxCUI 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

N471335001401 followed by a unit qualifier and the quantity

Package 71335-0014-01. 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 USP 50 mg is indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone hydrochloride tablets USP 50 mg 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 71335-0014

What is NDC 71335-0014?
71335-0014 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 091205

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

FDA NDC Directory listings under ANDA 091205
ProductStrengthForm · routeLabelerProduct NDC
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralAccord Healthcare, Inc.16729-081
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4925
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralRedpharm Drug67296-2282

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