Entecavir NDC 31722-833

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-833Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0833Add 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
31722-833-30	31722083330	30 TABLET in 1 BOTTLE (31722-833-30)Marketed from Aug 21, 2015
31722-833-31	31722083331	10 TABLET in 1 BLISTER PACK (31722-833-31)Marketed from Aug 21, 2015
31722-833-32	31722083332	100 TABLET in 1 CARTON (31722-833-32)Marketed from Aug 21, 2015
31722-833-90	31722083390	90 TABLET in 1 BOTTLE (31722-833-90)Marketed from Aug 21, 2015

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 anhydrous — .5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Camber Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205740
Marketing start: Aug 21, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Nucleoside Analog (EXT)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 31722-833_2b442999-71b5-88f6-e063-6394a90a9d6eSPL ID 2b442999-71b5-88f6-e063-6394a90a9d6eSPL set ID 01ec50a1-6c6c-46f0-8c74-73542b0a59c3RxCUI 485434, 485436UNII NNU2O4609D
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

N431722083330 followed by a unit qualifier and the quantity

Package 31722-0833-30. 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 9, 2025. 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)

Other NDCs under ANDA 205740

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

FDA NDC Directory listings under ANDA 205740
Product	Strength	Form · route	Labeler	Product NDC
Entecavir	Entecavir anhydrous 1 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-834