Prescription drug · NDA
Selzentry (maraviroc) NDC 49702-224
Maraviroc 300 mg/1 · Tablet, Film coated · Oral · ViiV Healthcare Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49702-224-18 | 49702022418 | 60 TABLET, FILM COATED in 1 BOTTLE (49702-224-18)Marketed from May 16, 2011 |
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)
- Selzentry
- Generic name (nonproprietary)
- maraviroc
- Active ingredients
- Maraviroc — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- ViiV Healthcare Company
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022128
- Marketing start
- Listing expires
- Other FDA classes
- Chemokine Co-receptor 5 Antagonists (Mechanism)
- Identifiers
- Product ID 49702-224_bd98c45d-446e-4023-882c-9c36d612f5a5SPL ID bd98c45d-446e-4023-882c-9c36d612f5a5SPL set ID 46f30ac5-c96b-429e-976d-8c5ee1c0761bRxCUI 728223, 728225, 729201, 729203, 1857921, 1857925UNII MD6P741W8A
- Pharmacologic class
- CCR5 Co-receptor Antagonist
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
N449702022418followed by a unit qualifier and the quantityPackage 49702-0224-18. 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)
SELZENTRY is indicated in combination with other antiretroviral agents for the treatment of only CCR5‑tropic human immunodeficiency virus type 1 (HIV‑1) infection in adult and pediatric patients weighing at least 2 kg. Limitations of Use • SELZENTRY is not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1 [see Microbiology ( 12.4 )]. SELZENTRY is a CCR5 co-receptor antagonist indicated in combination with other antiretroviral agents for the treatment of only CCR5-tropic HIV-1 infection in adults and pediatric patients weighing at least 2 kg. ( 1 ) Limitations of Use: • Not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022128
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.