Prescription drug · ANDA

Entecavir (entecavir anhydrous) NDC 42494-457

Entecavir anhydrous .5 mg/1 · Tablet · Oral · Cameron Pharmaceuticals

NDC codes

FDA NDC Directory
Product NDC (as listed)42494-457Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42494-0457Add 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
42494-457-304249404573030 TABLET in 1 BOTTLE (42494-457-30)Marketed from May 15, 2025

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 anhydrous
Active ingredients
Entecavir anhydrous — .5 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216857
Marketing start
Listing expires
Other FDA classes
Nucleoside Analog (EXT)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers
Product ID 42494-457_3ada45bd-97aa-4713-ad29-6e462668c108SPL ID 3ada45bd-97aa-4713-ad29-6e462668c108SPL set ID 92a5bebd-6408-463d-933c-bab8338a677eRxCUI 485434, 485436UNII NNU2O4609DUPC 0342494457305, 0342494458302
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

N442494045730 followed by a unit qualifier and the quantity

Package 42494-0457-30. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Entecavir is 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)

Other NDCs under ANDA 216857

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

FDA NDC Directory listings under ANDA 216857
ProductStrengthForm · routeLabelerProduct NDC
EntecavirEntecavir anhydrous .5 mg/1Tablet, Film coatedOralEpic Pharma, LLC42806-667
EntecavirEntecavir anhydrous 1 mg/1Tablet, Film coatedOralEpic Pharma, LLC42806-668
Entecavirentecavir anhydrousEntecavir anhydrous 1 mg/1TabletOralCameron Pharmaceuticals42494-458

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Entecavir (entecavir anhydrous) NDC 42494-457 | Med-Code