What is NDC 33342-238?

33342-238 is the product NDC for Nevirapine, Nevirapine 400 mg/1 tablet, extended release, listed with the FDA by Macleods Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nevirapine?

8 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nevirapine NDC 33342-238 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-238Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0238Add 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
33342-238-07	3334202380733342023807	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-238-07)Marketed from Oct 7, 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): Nevirapine
Generic name (nonproprietary): nevirapine
Active ingredients: Nevirapine — 400 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206879
Marketing start: Oct 7, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Non-Nucleoside Analog (EXT)Non-Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 33342-238_de3914b8-5c5c-4b11-a9f9-39f592d51c1dSPL ID de3914b8-5c5c-4b11-a9f9-39f592d51c1dSPL set ID 2620b114-f53f-44f1-8708-697e86343090RxCUI 1095712UNII 99DK7FVK1HUPC 0333342238078, 0333342238122
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

N433342023807 followed by a unit qualifier and the quantity

Package 33342-0238-07. 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 Aug 14, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Nevirapine extended-release tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 6 years of age or older with a body surface area (BSA) of 1.17 m 2 or greater [see Clinical Studies ( 14.1 , 14.2 )]. Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine extended-release tablets are not recommended to be initiated, unless the benefit outweighs the risk, in: • adult females with CD4 + cell counts greater than 250 cells/mm 3 or • adult males with CD4 + cell counts greater than 400 cells/mm 3 [see Warnin…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-238

What is NDC 33342-238?: 33342-238 is the product NDC for Nevirapine, Nevirapine 400 mg/1 tablet, extended release, listed with the FDA by Macleods Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nevirapine.
What is the active ingredient?: Nevirapine.
Who is the labeler?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nevirapine?: 8 other product NDCs are listed under this name. See all Nevirapine 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 Nevirapine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nevirapine	Nevirapine 200 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-004	33342-0004-09
Nevirapine	Nevirapine 400 mg/1	Tablet, Extended releaseOral	Mylan Pharmaceuticals Inc.	0378-4890	00378-4890-93
Nevirapine	Nevirapine 200 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-209	65162-0209-06
Nevirapine	Nevirapine 200 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-505	31722-0505-0131722-0505-0531722-0505-10+1 more
Nevirapine	Nevirapine 200 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-4050	00378-4050-91
Nevirapine	Nevirapine 200 mg/1	TabletOral	Micro Labs Limited	42571-131	42571-0131-2942571-0131-60
Nevirapine	Nevirapine 200 mg/1	TabletOral	Aurobindo Pharma Limited	65862-027	65862-0027-1065862-0027-60
Nevirapine	Nevirapine hemihydrate 50 mg/5mL	SuspensionOral	Aurobindo Pharma Limited	65862-057	65862-0057-1165862-0057-24