Prescription drug · ANDA
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate NDC 42385-929
Efavirenz 400 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Laurus Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42385-929-18 | 4238509291842385092918 | 180 TABLET, FILM COATED in 1 BOTTLE (42385-929-18)Marketed from May 14, 2020 | |
| 42385-929-30 | 4238509293042385092930 | 30 TABLET, FILM COATED in 1 BOTTLE (42385-929-30)Marketed from May 14, 2020 | |
| 42385-929-31 | 4238509293142385092931 | 30 TABLET, FILM COATED in 1 BOTTLE (42385-929-31)Marketed from May 14, 2020 | |
| 42385-929-82 | 4238509298242385092982 | 180 TABLET, FILM COATED in 1 BOTTLE (42385-929-82)Marketed from May 14, 2020 | |
| 42385-929-90 | 4238509299042385092990 | 90 TABLET, FILM COATED in 1 BOTTLE (42385-929-90)Marketed from May 14, 2020 | |
| 42385-929-91 | 4238509299142385092991 | 90 TABLET, FILM COATED in 1 BOTTLE (42385-929-91)Marketed from May 14, 2020 |
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)
- Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
- Generic name (nonproprietary)
- efavirenz, lamivudine and tenofovir disoproxil fumarate
- Active ingredients
- Efavirenz — 400 mg/1Lamivudine — 300 mg/1Tenofovir disoproxil fumarate — 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 213038
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Non-Nucleoside Analog (EXT)Non-Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)
- Identifiers
- Product ID 42385-929_80228c3a-152e-4170-9469-b4e13b137bcbSPL ID 80228c3a-152e-4170-9469-b4e13b137bcbSPL set ID 98342153-b9de-4318-aac4-9f8d19590cd7RxCUI 2001424UNII JE6H2O27P8, 2T8Q726O95, OTT9J7900IUPC 0342385929317
- Pharmacologic class
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus 1 Non-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
N442385092918followed by a unit qualifier and the quantityPackage 42385-0929-18. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg. Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are three-drug combination of efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor, and lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), both nucleo(t)side reverse transcriptase inhibitors and are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg. ( 1 )…
Excerpt only. Read the full label for complete information.
About NDC 42385-929
- What is NDC 42385-929?
- 42385-929 is the product NDC for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate, Efavirenz 400 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Laurus Labs Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate.
- What is the active ingredient?
- Efavirenz, Lamivudine, Tenofovir disoproxil fumarate.
- 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 Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate?
- 1 other product NDC are listed under this name. See all Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate | Efavirenz 600 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Laurus Labs Limited | 42385-928 | 42385-0928-3042385-0928-90 |