Entecavir NDC 43547-437

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-437Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0437Add 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
43547-437-03	43547043703	30 TABLET, FILM COATED in 1 BOTTLE (43547-437-03)Marketed from Apr 1, 2018
43547-437-09	43547043709	90 TABLET, FILM COATED in 1 BOTTLE (43547-437-09)Marketed from Apr 1, 2018
43547-437-50	43547043750	500 TABLET, FILM COATED in 1 BOTTLE (43547-437-50)Marketed from Apr 1, 2018

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 — 1 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Solco Healthcare LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208782
Marketing start: Apr 1, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Nucleoside Analog (EXT)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 43547-437_a5a51ce6-2c18-40de-b266-c3891132bbd1SPL ID a5a51ce6-2c18-40de-b266-c3891132bbd1SPL set ID bb1bb6dc-0120-46e2-ad1e-d9afc221fa16RxCUI 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

N443547043703 followed by a unit qualifier and the quantity

Package 43547-0437-03. 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 20, 2024. 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 208782

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

FDA NDC Directory listings under ANDA 208782
Product	Strength	Form · route	Labeler	Product NDC
Entecavir	Entecavir anhydrous .5 mg/1	Tablet, Film coatedOral	Solco Healthcare LLC	43547-436