Prescription drug · ANDA
Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate NDC 65862-497
Efavirenz 600 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-497-30 | 6586204973065862049730 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-497-30)Marketed from Mar 30, 2021 |
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, Emtricitabine And Tenofovir Disoproxil Fumarate
- Generic name (nonproprietary)
- efavirenz, emtricitabine and tenofovir disoproxil fumarate
- Active ingredients
- Efavirenz — 600 mg/1Emtricitabine — 200 mg/1Tenofovir disoproxil fumarate — 300 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 203041
- 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)Nucleosides (Chemical structure)
- Identifiers
- Product ID 65862-497_e45a9953-97a0-4885-acbd-5af0f22c4f74SPL ID e45a9953-97a0-4885-acbd-5af0f22c4f74SPL set ID 1b71df95-b1ce-4e40-908a-67fb336457f4RxCUI 643066UNII JE6H2O27P8, G70B4ETF4S, OTT9J7900I
- 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
N465862049730followed by a unit qualifier and the quantityPackage 65862-0497-30. 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)
Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet is a three-drug combination of efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor, and emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients…
Excerpt only. Read the full label for complete information.
About NDC 65862-497
- What is NDC 65862-497?
- 65862-497 is the product NDC for Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate, Efavirenz 600 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate.
- What is the active ingredient?
- Efavirenz, Emtricitabine, Tenofovir disoproxil fumarate.
- 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 Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate?
- 6 other product NDCs are listed under this name. See all Efavirenz, Emtricitabine 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, Emtricitabine 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, Emtricitabine and Tenofovir Disoproxil Fumarate | Efavirenz 600 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-736 | 31722-0736-30 |
| Efavirenz, emtricitabine and tenofovir disoproxil fumarate | Efavirenz 600 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Laurus Labs Limited | 42385-915 | 42385-0915-3042385-0915-90 |
| Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate | Efavirenz 600 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-138 | 33342-0138-07 |
| efavirenz, emtricitabine and tenofovir disoproxil fumarate | Efavirenz 600 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Cipla USA Inc. | 69097-210 | 69097-0210-02 |
| Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate | Efavirenz 600 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2565 | 72162-2565-03 |
| Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate | Efavirenz 600 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-5234 | 00093-5234-56 |
Other NDCs under ANDA 203041
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 |
|---|---|---|---|---|
| Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate | Efavirenz 600 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2565 |