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 NDC11-digit (billing)PackageCopy
31722-504-2531722050425250 TABLET, FILM COATED in 1 BOTTLE (31722-504-25)Marketed from Apr 27, 2018
31722-504-303172205043030 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.NDC labeler code 31722
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 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 .

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)

About NDC 31722-504

What is NDC 31722-504?
31722-504 is the product NDC for Efavirenz, Efavirenz 600 mg/1 tablet, film coated, listed with the FDA by Camber 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?
Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Efavirenz NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
EfavirenzEfavirenz 600 mg/1TabletOralMacleods Pharmaceuticals Limited33342-01333342-0013-07
EfavirenzEfavirenz 600 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-17272865-0172-2572865-0172-30
EfavirenzEfavirenz 600 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-04965862-0049-1065862-0049-30
EfavirenzEfavirenz 600 mg/1Tablet, Film coatedOralCipla USA Inc.69097-30169097-0301-02
EfavirenzEfavirenz 100 mg/1CapsuleOralAurobindo Pharma Limited65862-10565862-0105-1065862-0105-30

Other NDCs under ANDA 078886

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

FDA NDC Directory listings under ANDA 078886
ProductStrengthForm · routeLabelerProduct NDC
EfavirenzEfavirenz 600 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-172

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in