Prescription drug · ANDA
Efavirenz NDC 65862-049
Efavirenz 600 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-049-10 | 65862004910 | 3 BLISTER PACK in 1 CARTON (65862-049-10) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 21, 2018 | |
| 65862-049-30 | 65862004930 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-049-30)Marketed from Sep 21, 2018 |
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
- Generic name (nonproprietary)
- efavirenz
- Active ingredients
- Efavirenz — 600 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 077673
- 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)
- Identifiers
- Product ID 65862-049_f9982eb1-1e15-4fad-99f9-0f9da04fd058SPL ID f9982eb1-1e15-4fad-99f9-0f9da04fd058SPL set ID c5eedb5d-4cab-4056-a14a-ffdf67701355RxCUI 349477UNII JE6H2O27P8UPC 0365862049100
- Pharmacologic class
- Human Immunodeficiency Virus 1 Non-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
N465862004910followed by a unit qualifier and the quantityPackage 65862-0049-10. 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 .
Indications (excerpt from the label)
Efavirenz tablets in combination with other antiretroviral agents are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg. Efavirenz tablets are a non-nucleoside reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 65862-049
- What is NDC 65862-049?
- 65862-049 is the product NDC for Efavirenz, Efavirenz 600 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?
- Efavirenz.
- What is the active ingredient?
- Efavirenz.
- 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?
- 5 other product NDCs are listed under this name. See all Efavirenz NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Efavirenz 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 | Efavirenz 600 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-013 | 33342-0013-07 |
| Efavirenz | Efavirenz 600 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-172 | 72865-0172-2572865-0172-30 |
| Efavirenz | Efavirenz 600 mg/1 | Tablet, Film coatedOral | Cipla USA Inc. | 69097-301 | 69097-0301-02 |
| Efavirenz | Efavirenz 600 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-504 | 31722-0504-2531722-0504-30 |
| Efavirenz | Efavirenz 100 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-105 | 65862-0105-1065862-0105-30 |