What is NDC 65162-446?

65162-446 is the product NDC for Entecavir, Entecavir .5 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Entecavir?

27 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Entecavir NDC 65162-446 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-446Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0446Add 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	Copy
65162-446-03	6516204460365162044603	30 TABLET, FILM COATED in 1 BOTTLE (65162-446-03)Marketed from Nov 28, 2014

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): Entecavir
Generic name (nonproprietary): entecavir
Active ingredients: Entecavir — .5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Amneal Pharmaceuticals LLCNDC labeler code 65162
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206652
Marketing start: Nov 28, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Nucleoside Analog (EXT)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 65162-446_c0f7f2de-7a13-4703-9569-262ea1f20cffSPL ID c0f7f2de-7a13-4703-9569-262ea1f20cffSPL set ID 007a6ad8-4d23-4543-ae48-c651cac7dd7bRxCUI 485434, 485436UNII 5968Y6H45MUPC 0365162446036, 0365162449037
Pharmacologic class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor

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

N465162044603 followed by a unit qualifier and the quantity

Package 65162-0446-03. 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 Nov 24, 2019. This label includes a boxed warning.

Indications (excerpt from the label)

Entecavir tablets are indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. Entecavir tablets are a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. ( 1 )…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65162-446

What is NDC 65162-446?: 65162-446 is the product NDC for Entecavir, Entecavir .5 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Entecavir.
What is the active ingredient?: Entecavir.
Who is the labeler?: Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Entecavir?: 27 other product NDCs are listed under this name. See all Entecavir 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 Entecavir NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Entecavirentecavir anhydrous	Entecavir anhydrous .5 mg/1	TabletOral	Cameron Pharmaceuticals	42494-457	42494-0457-30
Entecavirentecavir anhydrous	Entecavir anhydrous 1 mg/1	TabletOral	Cameron Pharmaceuticals	42494-458	42494-0458-30
Entecavir	Entecavir .5 mg/1	Tablet, Film coatedOral	Yaopharma Co., Ltd.	50771-013	50771-0013-0150771-0013-02
Entecavir	Entecavir 1 mg/1	Tablet, Film coatedOral	Yaopharma Co., Ltd.	50771-014	50771-0014-01
Entecavir	Entecavir anhydrous .5 mg/1	Tablet, Film coatedOral	Epic Pharma, LLC	42806-667	42806-0667-30
Entecavir	Entecavir anhydrous 1 mg/1	Tablet, Film coatedOral	Epic Pharma, LLC	42806-668	42806-0668-30
Entecavir	Entecavir .5 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-589	51407-0589-30
Entecavir	Entecavir .5 mg/1	TabletOral	Carlsbad Technology, Inc.	61442-311	61442-0311-30
Entecavir	Entecavir .5 mg/1	Tablet, Film coatedOral	AvKARE	42291-261	42291-0261-30
Entecavir	Entecavir .5 mg/1	TabletOral	EPIC PHARMA, LLC	42806-658	42806-0658-30

All 28 Entecavir NDCs

Other NDCs under ANDA 206652

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

FDA NDC Directory listings under ANDA 206652
Product	Strength	Form · route	Labeler	Product NDC
Entecavir	Entecavir .5 mg/1	Tablet, Film coatedOral	AvKARE	42291-261
Entecavir	Entecavir 1 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-449