What is NDC 47335-326?

47335-326 is the product NDC for Naltrexone Hydrochloride, Naltrexone hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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 47335-326

NDC codes

FDA NDC Directory

Product NDC (as listed)47335-326Labeler and product segments. Claims need a package NDC.

Product NDC at billing width47335-0326Add 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
47335-326-08	47335032608	100 TABLET, FILM COATED in 1 BOTTLE (47335-326-08)Marketed from Feb 29, 2012
47335-326-18	47335032618	1000 TABLET, FILM COATED in 1 BOTTLE (47335-326-18)Marketed from Feb 29, 2012
47335-326-83	47335032683	30 TABLET, FILM COATED in 1 BOTTLE (47335-326-83)Marketed from Feb 29, 2012
47335-326-88	47335032688	100 TABLET, FILM COATED in 1 BOTTLE (47335-326-88)Marketed from Feb 29, 2012

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
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090356
Marketing start: Feb 29, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Opioid Antagonists (Mechanism)
Identifiers: Product ID 47335-326_536e22b1-cd99-a64a-e063-6394a90adc92SPL ID 536e22b1-cd99-a64a-e063-6394a90adc92SPL set ID 0f30f885-d0cd-4fa6-a8e0-142f08a56792RxCUI 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

N447335032608 followed by a unit qualifier and the quantity

Package 47335-0326-08. 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 Jun 4, 2026.

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 47335-326

What is NDC 47335-326?: 47335-326 is the product NDC for Naltrexone Hydrochloride, Naltrexone hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 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?: Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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	Aphena Pharma Solutions - Tennessee, LLC	53401-023	53401-0023-3053401-0023-3153401-0023-53
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	71335-3011	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	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	Bryant Ranch Prepack	72162-2529	72162-2529-0172162-2529-03
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 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
Product	Strength	Form · route	Labeler	Product NDC
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8579
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7036
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0306
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-2718
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2062
Naltrexone Hydrochloride	Naltrexone hydrochloride 50 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-199