What is NDC 61442-311?

61442-311 is the product NDC for Entecavir, Entecavir .5 mg/1 tablet, listed with the FDA by Carlsbad Technology, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Carlsbad Technology, Inc., NDC labeler code 61442. 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 61442-311 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61442-311Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61442-0311Add 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
61442-311-30	6144203113061442031130	30 TABLET in 1 BOTTLE, PLASTIC (61442-311-30)Marketed from Nov 10, 2021

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
Route: Oral
Labeler: Carlsbad Technology, Inc.NDC labeler code 61442
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208195
Marketing start: Nov 10, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Nucleoside Analog (EXT)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 61442-311_48618328-e6d6-2aa2-e063-6294a90a1d00SPL ID 48618328-e6d6-2aa2-e063-6294a90a1d00SPL set ID 1a905283-0057-a7dd-e063-6394a90a1909RxCUI 485434UNII 5968Y6H45M
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

N461442031130 followed by a unit qualifier and the quantity

Package 61442-0311-30. 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 Jan 14, 2026. 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 is 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 61442-311

What is NDC 61442-311?: 61442-311 is the product NDC for Entecavir, Entecavir .5 mg/1 tablet, listed with the FDA by Carlsbad Technology, Inc.. 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?: Carlsbad Technology, Inc., NDC labeler code 61442. 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	Tablet, Film coatedOral	AvKARE	42291-261	42291-0261-30
Entecavir	Entecavir .5 mg/1	TabletOral	EPIC PHARMA, LLC	42806-658	42806-0658-30
Entecavir	Entecavir 1 mg/1	TabletOral	EPIC PHARMA, LLC	42806-659	42806-0659-30

All 28 Entecavir NDCs

Other NDCs under ANDA 208195

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

FDA NDC Directory listings under ANDA 208195
Product	Strength	Form · route	Labeler	Product NDC
Entecavir	Entecavir .5 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-589