What is NDC 0378-4050?

0378-4050 is the product NDC for Nevirapine, Nevirapine 200 mg/1 tablet, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 0378-4050 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-4050Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-4050Add 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
0378-4050-91	0037840509100378405091	60 TABLET in 1 BOTTLE, PLASTIC (0378-4050-91)Marketed from May 22, 2012

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 200 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202523
Marketing start: May 22, 2012
Listing expires: Dec 31, 2027
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 0378-4050_9eeacada-81f4-48c6-b924-515efdb2b219SPL ID 9eeacada-81f4-48c6-b924-515efdb2b219SPL set ID c6e93829-7024-48f6-8023-da6ff27dfc0aRxCUI 199422UNII 99DK7FVK1HUPC 0303784050910
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

N400378405091 followed by a unit qualifier and the quantity

Package 00378-4050-91. 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 Jul 15, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Nevirapine is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1 , 14.2) ]. Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine is 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 Warnings and Precautions (5.1) ] . • Nevirapine is an NNRTI indicated in combination with other antiretroviral agents f…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-4050

What is NDC 0378-4050?: 0378-4050 is the product NDC for Nevirapine, Nevirapine 200 mg/1 tablet, listed with the FDA by Mylan Pharmaceuticals Inc.. 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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	Macleods Pharmaceuticals Limited	33342-238	33342-0238-07
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	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