Efavirenz NDC 31722-504

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-504Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0504Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
31722-504-25	31722050425	250 TABLET, FILM COATED in 1 BOTTLE (31722-504-25)Marketed from Apr 27, 2018
31722-504-30	31722050430	30 TABLET, FILM COATED in 1 BOTTLE (31722-504-30)Marketed from Apr 27, 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: Camber Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078886
Marketing start: Apr 27, 2018
Listing expires: Dec 31, 2026
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 31722-504_fbbb1836-2fa8-f7a6-e053-6394a90a8718SPL ID fbbb1836-2fa8-f7a6-e053-6394a90a8718SPL set ID 6d625901-fef2-4c93-9619-f8991d65413dRxCUI 349477UNII JE6H2O27P8UPC 0331722504300
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

N431722050425 followed by a unit qualifier and the quantity

Package 31722-0504-25. 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 May 15, 2023.

Indications (excerpt from the label)

Efavirenz tablets in combination with other antiretroviral agents is 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078886

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078886
Product	Strength	Form · route	Labeler	Product NDC
Efavirenz	Efavirenz 600 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-172