Prescription drug · ANDA
Lamivudine NDC 60429-354
Lamivudine 300 mg/1 · Tablet, Film coated · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60429-354-30 | 6042903543060429035430 | 30 TABLET, FILM COATED in 1 BOTTLE (60429-354-30)Marketed from Dec 2, 2011 |
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)
- Lamivudine
- Generic name (nonproprietary)
- lamivudine
- Active ingredients
- Lamivudine — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Golden State Medical Supply, Inc.NDC labeler code 60429
- 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 60429-354_445d3e2e-7b0c-29ad-e063-6394a90a8ce0SPL ID 445d3e2e-7b0c-29ad-e063-6394a90a8ce0SPL set ID f3637209-303e-4232-ae79-07315a990973RxCUI 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
N460429035430followed by a unit qualifier and the quantityPackage 60429-0354-30. 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)
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.
About NDC 60429-354
- What is NDC 60429-354?
- 60429-354 is the product NDC for Lamivudine, Lamivudine 300 mg/1 tablet, film coated, listed with the FDA by Golden State Medical Supply, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lamivudine.
- What is the active ingredient?
- Lamivudine.
- Who is the labeler?
- Golden State Medical Supply, Inc., NDC labeler code 60429. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lamivudine?
- 23 other product NDCs are listed under this name. See all Lamivudine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lamivudine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lamivudine | Lamivudine 150 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1459 | 67046-1459-03 |
| Lamivudine | Lamivudine 150 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-720 | 60687-0720-21 |
| Lamivudine | Lamivudine 150 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-001 | 33342-0001-09 |
| Lamivudine | Lamivudine 300 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-002 | 33342-0002-07 |
| lamivudine | Lamivudine 100 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-001 | 31722-0001-0231722-0001-60 |
| Lamivudine | Lamivudine 150 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-710 | 64380-0710-03 |
| Lamivudine | Lamivudine 300 mg/1 | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-711 | 64380-0711-04 |
| Lamivudine | Lamivudine 150 mg/1 | TabletOral | Ingenus Pharmaceuticals, LLC | 50742-623 | 50742-0623-60 |
| Lamivudine | Lamivudine 300 mg/1 | TabletOral | Ingenus Pharmaceuticals, LLC | 50742-624 | 50742-0624-60 |
| Lamivudine | Lamivudine 10 mg/mL | SolutionOral | Rising Pharma Holdings, Inc. | 57237-274 | 57237-0274-24 |
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 150 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6583 |
| Lamivudine | Lamivudine 150 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-353 |
| Lamivudine | Lamivudine 150 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3251 |
| Lamivudine | Lamivudine 300 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3252 |
| Lamivudine | Lamivudine 150 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-720 |