Prescription drug · ANDA
Abacavir and Lamivudine NDC 42385-962
Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1 · Tablet, Film coated · Oral · Laurus Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42385-962-18 | 4238509621842385096218 | 180 TABLET, FILM COATED in 1 BOTTLE (42385-962-18)Marketed from Jul 25, 2022 | |
| 42385-962-30 | 4238509623042385096230 | 30 TABLET, FILM COATED in 1 BOTTLE (42385-962-30)Marketed from Jul 25, 2022 | |
| 42385-962-90 | 4238509629042385096290 | 90 TABLET, FILM COATED in 1 BOTTLE (42385-962-90)Marketed from Jul 25, 2022 |
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)
- Abacavir and Lamivudine
- Generic name (nonproprietary)
- abacavir and lamivudine
- Active ingredients
- Abacavir sulfate — 600 mg/1Lamivudine — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Laurus Labs LimitedNDC labeler code 42385
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216332
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A1 Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
- Identifiers
- Product ID 42385-962_6ce5a446-f6a1-4efe-8a69-fd6ddf1a8ab2SPL ID 6ce5a446-f6a1-4efe-8a69-fd6ddf1a8ab2
- 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
N442385096218followed by a unit qualifier and the quantityPackage 42385-0962-18. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 42385-962
- What is NDC 42385-962?
- 42385-962 is the product NDC for Abacavir and Lamivudine, Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1 tablet, film coated, listed with the FDA by Laurus Labs Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Abacavir and Lamivudine.
- What is the active ingredient?
- Abacavir sulfate, Lamivudine.
- Who is the labeler?
- Laurus Labs Limited, NDC labeler code 42385. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Abacavir and Lamivudine?
- 5 other product NDCs are listed under this name. See all Abacavir and Lamivudine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Abacavir and 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) |
|---|---|---|---|---|---|
| ABACAVIR and LAMIVUDINE | Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-838 | 31722-0838-30 |
| Abacavir and Lamivudine | Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-440 | 33342-0440-0733342-0440-1433342-0440-98 |
| Abacavir and Lamivudine | Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-335 | 65862-0335-1065862-0335-30 |
| Abacavir and Lamivudine | Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-288 | — |
| Abacavir and Lamivudine | Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1 | Tablet, Film coatedOral | Cipla USA Inc. | 69097-362 | 69097-0362-02 |