Prescription drug · ANDA
Lamivudine NDC 65862-025
Lamivudine 150 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-025-10 | 65862002510 | 6 BLISTER PACK in 1 CARTON (65862-025-10) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 21, 2016 | |
| 65862-025-60 | 65862002560 | 60 TABLET, FILM COATED in 1 BOTTLE (65862-025-60)Marketed from Nov 21, 2016 |
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 — 150 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077464
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
- Identifiers
- Product ID 65862-025_0c6a0ca4-d63c-4018-909a-d9e7a2821ed4SPL ID 0c6a0ca4-d63c-4018-909a-d9e7a2821ed4SPL set ID a8a492ab-396a-4b7c-99b3-bcb6d3386f71RxCUI 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
N465862002510followed by a unit qualifier and the quantityPackage 65862-0025-10. 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 65862-025
- What is NDC 65862-025?
- 65862-025 is the product NDC for Lamivudine, Lamivudine 150 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, 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?
- Aurobindo Pharma Limited, NDC labeler code 65862. 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?
- 24 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 |