NDC codes

FDA NDC Directory
Product NDC (as listed)31722-584Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0584Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
31722-584-603172205846060 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

N431722058460 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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