Prescription drug · ANDA
Entecavir NDC 31722-834
Entecavir anhydrous 1 mg/1 · Tablet · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-834-30 | 3172208343031722083430 | 30 TABLET in 1 BOTTLE (31722-834-30)Marketed from Aug 21, 2015 | |
| 31722-834-31 | 3172208343131722083431 | 10 TABLET in 1 BLISTER PACK (31722-834-31)Marketed from Aug 21, 2015 | |
| 31722-834-32 | 3172208343231722083432 | 100 TABLET in 1 CARTON (31722-834-32)Marketed from Aug 21, 2015 | |
| 31722-834-90 | 3172208349031722083490 | 90 TABLET in 1 BOTTLE (31722-834-90)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 — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205740
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Analog (EXT)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
- Identifiers
- Product ID 31722-834_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
N431722083430followed by a unit qualifier and the quantityPackage 31722-0834-30. 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 31722-834
- What is NDC 31722-834?
- 31722-834 is the product NDC for Entecavir, Entecavir anhydrous 1 mg/1 tablet, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Entecavir.
- What is the active ingredient?
- Entecavir anhydrous.
- Who is the labeler?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 205740
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 anhydrous .5 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-833 |