Prescription drug · ANDA
Lamivudine NDC 60505-3251
Lamivudine 150 mg/1 · Tablet, Film coated · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-3251-6 | 60505325106 | 60 TABLET, FILM COATED in 1 BOTTLE (60505-3251-6)Marketed from Dec 2, 2011 | |
| 60505-3251-8 | 60505325108 | 1000 TABLET, FILM COATED in 1 BOTTLE (60505-3251-8)Marketed from Dec 2, 2011 |
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 — 150 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 091606
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
- Identifiers
- Product ID 60505-3251_2cca5476-aba6-0525-0bb5-890f2ca25bb7SPL ID 2cca5476-aba6-0525-0bb5-890f2ca25bb7SPL set ID 34c02bcc-d6ff-99d4-8e6a-4a91908adca8RxCUI 199147, 349491UNII 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
N460505325106followed by a unit qualifier and the quantityPackage 60505-3251-06. 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 are a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: The dosage of this product is for HIV-1 and not for HBV. Lamivudine tablets are a nucleoside analogue reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Limitations of Use: The dosage of this product is for HIV-1 and not for HBV. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091606
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 300 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3252 |
| Lamivudine | Lamivudine 300 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-354 |
| Lamivudine | Lamivudine 150 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-353 |
| Lamivudine | Lamivudine 150 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6583 |
| Lamivudine | Lamivudine 150 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-720 |