Prescription drug · ANDA
Lamivudine NDC 60505-3250
Lamivudine 100 mg/1 · Tablet, Film coated · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-3250-6 | 60505325006 | 60 TABLET, FILM COATED in 1 BOTTLE (60505-3250-6)Marketed from Jan 3, 2014 |
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)
- Lamivudine
- Generic name (nonproprietary)
- lamivudine
- Active ingredients
- Lamivudine — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Apotex Corp.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202941
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
- Identifiers
- Product ID 60505-3250_57b50cc9-4140-66b7-ec3c-e10a213dae03SPL ID 57b50cc9-4140-66b7-ec3c-e10a213dae03SPL set ID 87095352-c088-74b1-7be0-d3e293a90611RxCUI 205328UNII 2T8Q726O95
- Pharmacologic class
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; Human Immunodeficiency 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
N460505325006followed by a unit qualifier and the quantityPackage 60505-3250-06. 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)
Lamivudine tablets (HBV) are indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation [ see Clinical Studies ( 14.1 , 14.2 ) ]. The following points should be considered when initiating therapy with lamivudine tablets (HBV): Due to high rates of resistance development in treated patients, initiation of treatment with lamivudine tablets (HBV) should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate. Lamivudine tablets (HBV) have not been evaluated in patients co-infected with human immunodeficiency v…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202941
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 |
|---|---|---|---|---|
| Lamivudine | Lamivudine 100 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-866 |