NDC codes

FDA NDC Directory
Product NDC (as listed)62135-242Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0242Add 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
62135-242-306213502423030 TABLET, FILM COATED in 1 BOTTLE (62135-242-30)Marketed from Jan 5, 2022
62135-242-606213502426060 TABLET, FILM COATED in 1 BOTTLE (62135-242-60)Marketed from Jun 11, 2024
62135-242-906213502429090 TABLET, FILM COATED in 1 BOTTLE (62135-242-90)Marketed from Jan 5, 2022

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207905
Marketing start
Listing expires
Other FDA classes
Opioid Antagonists (Mechanism)
Identifiers
Product ID 62135-242_549b89e5-cdb5-6f77-e063-6394a90a58c7SPL ID 549b89e5-cdb5-6f77-e063-6394a90a58c7SPL set ID adb7c4dc-221a-4d91-9687-0d78913a92adRxCUI 1483744UNII Z6375YW9SFUPC 0362135242909, 0362135242602, 0362135242305
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

N462135024230 followed by a unit qualifier and the quantity

Package 62135-0242-30. 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

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 tablets 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)

Other NDCs under ANDA 207905

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

FDA NDC Directory listings under ANDA 207905
ProductStrengthForm · routeLabelerProduct NDC
Naltrexone HydrochlorideNaltrexone hydrochloride 50 mg/1Tablet, Film coatedOralHeritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc23155-886

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