Prescription drug · ANDA
Entecavir NDC 65862-842
Entecavir 1 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-842-30 | 6586208423065862084230 | 1 BOTTLE in 1 CARTON (65862-842-30) / 30 TABLET in 1 BOTTLEMarketed from Aug 26, 2015 | |
| 65862-842-90 | 6586208429065862084290 | 1 BOTTLE in 1 CARTON (65862-842-90) / 90 TABLET in 1 BOTTLEMarketed from Aug 26, 2015 | |
| 65862-842-99 | 6586208429965862084299 | 1 BOTTLE in 1 CARTON (65862-842-99) / 1000 TABLET in 1 BOTTLEMarketed from Aug 26, 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 — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206217
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Analog (EXT)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
- Identifiers
- Product ID 65862-842_81e4395b-8a3e-466e-b039-0a804f171b43SPL ID 81e4395b-8a3e-466e-b039-0a804f171b43SPL set ID def332bf-2906-4a6c-b85d-dfb56bb94312RxCUI 485434, 485436UNII 5968Y6H45MUPC 0365862841308
- 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
N465862084230followed by a unit qualifier and the quantityPackage 65862-0842-30. 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.
About NDC 65862-842
- What is NDC 65862-842?
- 65862-842 is the product NDC for Entecavir, Entecavir 1 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Entecavir.
- What is the active ingredient?
- Entecavir.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Entecavir?
- 27 other product NDCs are listed under this name. See all Entecavir NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Entecavir products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Entecavirentecavir anhydrous | Entecavir anhydrous .5 mg/1 | TabletOral | Cameron Pharmaceuticals | 42494-457 | 42494-0457-30 |
| Entecavirentecavir anhydrous | Entecavir anhydrous 1 mg/1 | TabletOral | Cameron Pharmaceuticals | 42494-458 | 42494-0458-30 |
| Entecavir | Entecavir .5 mg/1 | Tablet, Film coatedOral | Yaopharma Co., Ltd. | 50771-013 | 50771-0013-0150771-0013-02 |
| Entecavir | Entecavir 1 mg/1 | Tablet, Film coatedOral | Yaopharma Co., Ltd. | 50771-014 | 50771-0014-01 |
| Entecavir | Entecavir anhydrous .5 mg/1 | Tablet, Film coatedOral | Epic Pharma, LLC | 42806-667 | 42806-0667-30 |
| Entecavir | Entecavir anhydrous 1 mg/1 | Tablet, Film coatedOral | Epic Pharma, LLC | 42806-668 | 42806-0668-30 |
| Entecavir | Entecavir .5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-589 | 51407-0589-30 |
| Entecavir | Entecavir .5 mg/1 | TabletOral | Carlsbad Technology, Inc. | 61442-311 | 61442-0311-30 |
| Entecavir | Entecavir .5 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-261 | 42291-0261-30 |
| Entecavir | Entecavir .5 mg/1 | TabletOral | EPIC PHARMA, LLC | 42806-658 | 42806-0658-30 |
Other NDCs under ANDA 206217
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 | American Health Packaging | 60687-216 |
| Entecavir | Entecavir .5 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-841 |