NDC codes

FDA NDC Directory
Product NDC (as listed)65862-105Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0105Add 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
65862-105-10658620105103 BLISTER PACK in 1 CARTON (65862-105-10) / 10 CAPSULE in 1 BLISTER PACKMarketed from Dec 15, 2017
65862-105-306586201053030 CAPSULE in 1 BOTTLE (65862-105-30)Marketed from Dec 15, 2017

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 — 100 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078064
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 65862-105_a02dd4c8-6159-48b0-a79c-c362f1f4daf9SPL ID a02dd4c8-6159-48b0-a79c-c362f1f4daf9SPL set ID 4c57ad7f-321a-46c8-851a-c895466eb8e1RxCUI 205290, 205291, 205292UNII JE6H2O27P8
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

N465862010510 followed by a unit qualifier and the quantity

Package 65862-0105-10. 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 capsules 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.

Full label on DailyMed (opens in a new tab)

About NDC 65862-105

What is NDC 65862-105?
65862-105 is the product NDC for Efavirenz, Efavirenz 100 mg/1 capsule, 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.

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 600 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-50431722-0504-2531722-0504-30

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