Prescription drug · ANDA
Nevirapine NDC 31722-505
Nevirapine 200 mg/1 · Tablet · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-505-01 | 3172205050131722050501 | 100 TABLET in 1 BOTTLE (31722-505-01)Marketed from May 23, 2012 | |
| 31722-505-05 | 3172205050531722050505 | 500 TABLET in 1 BOTTLE (31722-505-05)Marketed from May 23, 2012 | |
| 31722-505-10 | 3172205051031722050510 | 1000 TABLET in 1 BOTTLE (31722-505-10)Marketed from May 23, 2012 | |
| 31722-505-60 | 3172205056031722050560 | 60 TABLET in 1 BOTTLE (31722-505-60)Marketed from May 23, 2012 |
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
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078584
- 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 31722-505_e5515515-0ee0-e288-e053-2995a90a3d7cSPL ID e5515515-0ee0-e288-e053-2995a90a3d7cSPL set ID 61409678-d2f6-42cd-b03d-b26b11b39641RxCUI 199422UNII 99DK7FVK1H
- 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
N431722050501followed by a unit qualifier and the quantityPackage 31722-0505-01. 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 tablets are 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 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/mm3 [see Warnings and Precautions (5.1) ] . Nevirapine tablet is an NNRTI indicated in combination with other anti…
Excerpt only. Read the full label for complete information.
About NDC 31722-505
- What is NDC 31722-505?
- 31722-505 is the product NDC for Nevirapine, Nevirapine 200 mg/1 tablet, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 4 package NDCs, 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?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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.
Related NDCs: other Nevirapine products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | 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 |