Prescription drug · ANDA
Abacavir and Lamivudine NDC 33342-440
Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1 · Tablet, Film coated · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-440-07 | 33342044007 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-440-07)Marketed from Dec 20, 2024 | |
| 33342-440-14 | 33342044014 | 5 BLISTER PACK in 1 CARTON (33342-440-14) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-440-02)Marketed from Dec 20, 2024 | |
| 33342-440-98 | 33342044098 | 10 BLISTER PACK in 1 CARTON (33342-440-98) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-440-02)Marketed from Dec 20, 2024 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212663
- 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 33342-440_42b22ad0-4838-43fd-9bf7-f22dafc7c352SPL ID 42b22ad0-4838-43fd-9bf7-f22dafc7c352SPL set ID d36624c8-d773-4f99-81fc-433fae17feb3RxCUI 602393UNII J220T4J9Q2, 2T8Q726O95UPC 0333342440075
- 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
N433342044007followed by a unit qualifier and the quantityPackage 33342-0440-07. 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)
Abacavir and lamivudine tablets, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Abacavir and lamivudine tablets, a combination of abacavir and lamivudine, both nucleoside analogue HIV-1 reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 )
Excerpt only. Read the full label for complete information.