Prescription drug · ANDA
Adefovir dipivoxil NDC 60505-3947
Adefovir dipivoxil 10 mg/1 · Tablet · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-3947-3 | 60505394703 | 1 BOTTLE in 1 CARTON (60505-3947-3) / 30 TABLET in 1 BOTTLEMarketed from Sep 25, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Adefovir dipivoxil
- Generic name (nonproprietary)
- adefovir dipivoxil
- Active ingredients
- Adefovir dipivoxil — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Apotex Corp.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205459
- Marketing start
- Marketing end
- Other FDA classes
- Nucleoside Analog (EXT)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
- Identifiers
- Product ID 60505-3947_bd0233d0-e141-a321-66a5-4afd09dbabfeSPL ID bd0233d0-e141-a321-66a5-4afd09dbabfeSPL set ID 08e07fae-3191-b6a3-c894-d3a8cc53923fRxCUI 881341UNII U6Q8Z01514UPC 0360505394739
- 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
N460505394703followed by a unit qualifier and the quantityPackage 60505-3947-03. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Adefovir dipivoxil tablets are indicated for the treatment of chronic hepatitis B in patients 12 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. This indication is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg- chronic hepatitis B with compensated liver function, and with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function. For patients 12 to less than 18 years of age, the indication is based on virological and biochemical resp…
Excerpt only. Read the full label for complete information.