Prescription drug · ANDA
Maraviroc NDC 72319-025
Maraviroc 300 mg/1 · Tablet, Film coated · Oral · i3 Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72319-025-02 | 72319002502 | 60 TABLET, FILM COATED in 1 BOTTLE (72319-025-02)Marketed from Sep 15, 2023 |
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)
- Maraviroc
- Generic name (nonproprietary)
- maraviroc
- Active ingredients
- Maraviroc — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- i3 Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217114
- Marketing start
- Listing expires
- Other FDA classes
- Chemokine Co-receptor 5 Antagonists (Mechanism)
- Identifiers
- Product ID 72319-025_0416607a-fd74-87e3-e063-6294a90ae6b5SPL ID 0416607a-fd74-87e3-e063-6294a90ae6b5SPL set ID f7b9c67b-10c6-45b5-b2a8-952cd350b0b1RxCUI 728223, 728225UNII MD6P741W8AUPC 0372319024023, 0372319025020
- 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
N472319002502followed by a unit qualifier and the quantityPackage 72319-0025-02. 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)
Maraviroc 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 2 years of age and older weighing at least 10 kg. Limitations of Use Maraviroc is not recommended in patients with dual/mixed- or CXCR4-tropic HIV- 1 [see Microbiology (12.4) ] . Maraviroc 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 2 years of age and older weighing at least 10 kg. ( 1 ) Limitations of Use: • Not recommended in patients with dual/mixed- or CXCR4-tropic…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217114
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Maraviroc | Maraviroc 150 mg/1 | Tablet, Film coatedOral | A2A Integrated Pharmaceuticals | 73141-024 |
| Maraviroc | Maraviroc 300 mg/1 | Tablet, Film coatedOral | A2A Integrated Pharmaceuticals | 73141-025 |
| Maraviroc | Maraviroc 150 mg/1 | Tablet, Film coatedOral | i3 Pharmaceuticals, LLC | 72319-024 |
| Maraviroc | Maraviroc 150 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-8010 |