Prescription drug · ANDA
Entecavir NDC 42806-659
Entecavir 1 mg/1 · Tablet · Oral · EPIC PHARMA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-659-30 | 42806065930 | 30 TABLET in 1 BOTTLE, PLASTIC (42806-659-30)Marketed from Jun 2, 2020 |
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
- Route
- Oral
- Labeler
- EPIC PHARMA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212126
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Analog (EXT)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
- Identifiers
- Product ID 42806-659_db290579-c9e1-44be-b03c-ad8a7efe5ce1SPL ID db290579-c9e1-44be-b03c-ad8a7efe5ce1SPL set ID af4f47e2-f556-40f2-a0fd-ff81e9f27429RxCUI 485434, 485436UNII 5968Y6H45MUPC 0342806658307, 0342806659304
- 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
N442806065930followed by a unit qualifier and the quantityPackage 42806-0659-30. 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 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.
Other NDCs under ANDA 212126
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Entecavir | Entecavir .5 mg/1 | TabletOral | EPIC PHARMA, LLC | 42806-658 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.