Entecavir NDC 68382-921

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-921Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0921Add 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
68382-921-01	68382092101	100 TABLET, FILM COATED in 1 BOTTLE (68382-921-01)Marketed from Aug 10, 2017
68382-921-06	68382092106	30 TABLET, FILM COATED in 1 BOTTLE (68382-921-06)Marketed from Aug 10, 2017
68382-921-16	68382092116	90 TABLET, FILM COATED in 1 BOTTLE (68382-921-16)Marketed from Aug 10, 2017
68382-921-77	68382092177	10 BLISTER PACK in 1 CARTON (68382-921-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-921-30)Marketed from Aug 10, 2017

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 — 1 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Zydus Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206745
Marketing start: Aug 10, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Nucleoside Analog (EXT)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 68382-921_b9646f09-8d5b-4271-b2b1-b1d66a91ed73SPL ID b9646f09-8d5b-4271-b2b1-b1d66a91ed73SPL set ID b4fd0e22-ad23-4f51-9b98-95182f63c2ebRxCUI 485434, 485436UNII 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

N468382092101 followed by a unit qualifier and the quantity

Package 68382-0921-01. 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 Oct 5, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

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 ) 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206745

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

FDA NDC Directory listings under ANDA 206745
Product	Strength	Form · route	Labeler	Product NDC
Entecavir	Entecavir .5 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-920
Entecavir	Entecavir .5 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1019
Entecavir	Entecavir 1 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1020