Prescription drug · ANDA
Nevirapine NDC 33342-238
Nevirapine 400 mg/1 · Tablet, Extended release · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-238-07 | 33342023807 | 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206879
- Marketing start
- Listing expires
- 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
N433342023807followed by a unit qualifier and the quantityPackage 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 . 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.