Prescription drug · ANDA
Raltegravir NDC 31722-584
Raltegravir potassium 400 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-584-60 | 31722058460 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-584-60)Marketed from Dec 19, 2024 |
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)
- Raltegravir
- Generic name (nonproprietary)
- raltegravir
- Active ingredients
- Raltegravir potassium — 400 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203540
- Marketing start
- Listing expires
- Other FDA classes
- HIV Integrase Inhibitors (Mechanism)
- Identifiers
- Product ID 31722-584_55c7c6ef-cc60-1f7e-e063-6294a90ac6beSPL ID 55c7c6ef-cc60-1f7e-e063-6294a90ac6beSPL set ID 090aa265-9fc8-4aea-81fe-ce052c3f38dfRxCUI 744842UNII 43Y000U234UPC 0331722584609
- Pharmacologic class
- Human Immunodeficiency Virus Integrase Strand Transfer 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
N431722058460followed by a unit qualifier and the quantityPackage 31722-0584-60. 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 .
Indications (excerpt from the label)
Adult Patients: Raltegravir tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients. Pediatric Patients: Raltegravir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg. Adult Patients: Raltegravir tablets are human immunodeficiency virus integrase strand transfer inhibitors (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients ( 1 ). Pediatric Patients: Raltegravir tablets are indicated in combination with other antiretrov…
Excerpt only. Read the full label for complete information.
About NDC 31722-584
- What is NDC 31722-584?
- 31722-584 is the product NDC for Raltegravir, Raltegravir potassium 400 mg/1 tablet, film coated, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Raltegravir.
- What is the active ingredient?
- Raltegravir potassium.
- 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 Raltegravir?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.