What is NDC 65162-209?

65162-209 is the product NDC for Nevirapine, Nevirapine 200 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 65162-209 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-209Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0209Add 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
65162-209-06	6516202090665162020906	60 TABLET in 1 BOTTLE (65162-209-06)Marketed from Apr 30, 2014

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 — 200 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals LLCNDC labeler code 65162
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078195
Marketing start: Apr 30, 2014
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 65162-209_fd384f73-fd86-4750-8d30-ecbb4289572aSPL ID fd384f73-fd86-4750-8d30-ecbb4289572aSPL set ID 4f065674-4719-4c79-ba0d-549040d77f17RxCUI 199422UNII 99DK7FVK1HUPC 0365162209068
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

N465162020906 followed by a unit qualifier and the quantity

Package 65162-0209-06. 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 30, 2012. This label includes a boxed warning.

Indications (excerpt from the label)

Nevirapine tablets, USP are indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principal clinical trial (BI 1090) that demonstrated prolonged suppression of HIV-1 RNA and two smaller supportive trials, one of which (BI 1046) is described below. Additional important information regarding the use of Nevirapine tablets, USP for the treatment of HIV-1 infection: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, Nevirapine tablets, USP should not be initiated in adult females with CD4 + cell counts greater than 250 cells/mm 3 or in adult males with CD4 + cell cou…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65162-209

What is NDC 65162-209?: 65162-209 is the product NDC for Nevirapine, Nevirapine 200 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. 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?: Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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	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