Prescription drug · ANDA
Efavirenz NDC 72865-172
Efavirenz 600 mg/1 · Tablet, Film coated · Oral · XLCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72865-172-25 | 72865017225 | 250 TABLET, FILM COATED in 1 BOTTLE (72865-172-25)Marketed from May 29, 2021 | |
| 72865-172-30 | 72865017230 | 30 TABLET, FILM COATED in 1 BOTTLE (72865-172-30)Marketed from May 29, 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
- Generic name (nonproprietary)
- efavirenz
- Active ingredients
- Efavirenz — 600 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- XLCare Pharmaceuticals Inc.NDC labeler code 72865
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078886
- 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 72865-172_f21e4fb1-352d-7105-e053-2995a90a0588SPL ID f21e4fb1-352d-7105-e053-2995a90a0588SPL set ID 966b815d-1d78-4b54-8f00-c5a0b67c78beRxCUI 349477UNII JE6H2O27P8UPC 0372865172308
- 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
N472865017225followed by a unit qualifier and the quantityPackage 72865-0172-25. 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 is 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 72865-172
- What is NDC 72865-172?
- 72865-172 is the product NDC for Efavirenz, Efavirenz 600 mg/1 tablet, film coated, listed with the FDA by XLCare Pharmaceuticals Inc.. 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?
- XLCare Pharmaceuticals Inc., NDC labeler code 72865. 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 | Aurobindo Pharma Limited | 65862-049 | 65862-0049-1065862-0049-30 |
| 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 |
Other NDCs under ANDA 078886
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 | Efavirenz 600 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-504 |