What is NDC 69097-301?

69097-301 is the product NDC for Efavirenz, Efavirenz 600 mg/1 tablet, film coated, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Cipla USA Inc., NDC labeler code 69097. 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?

6 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Efavirenz NDC 69097-301 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-301Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0301Add 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
69097-301-02	6909703010269097030102	30 TABLET, FILM COATED in 1 BOTTLE (69097-301-02)Marketed from Jun 18, 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: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204766
Marketing start: Jun 18, 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 69097-301_20c14bd6-1106-433b-83ab-c2167b873987SPL ID 20c14bd6-1106-433b-83ab-c2167b873987SPL set ID 92603fa5-7a2c-4bfb-9a70-aadb4fba952cRxCUI 349477UNII 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

N469097030102 followed by a unit qualifier and the quantity

Package 69097-0301-02. 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 Mar 31, 2024.

Indications (excerpt from the label)

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 3.5kg. ( 1 ) Efavirenz 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-301

What is NDC 69097-301?: 69097-301 is the product NDC for Efavirenz, Efavirenz 600 mg/1 tablet, film coated, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, 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?: Cipla USA Inc., NDC labeler code 69097. 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?: 6 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
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	Aurobindo Pharma Limited	65862-049	65862-0049-1065862-0049-30
Efavirenz	Efavirenz 600 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-504	31722-0504-2531722-0504-30
Efavirenz	Efavirenz 50 mg/1	CapsuleOral	Aurobindo Pharma Limited	65862-104	65862-0104-1065862-0104-30
Efavirenz	Efavirenz 200 mg/1	CapsuleOral	Aurobindo Pharma Limited	65862-106	65862-0106-0965862-0106-1065862-0106-30+1 more