Prescription drug · NDA
Isentress (Raltegravir) NDC 0006-3603
Raltegravir potassium 100 mg/1 · Granule, For suspension · Oral · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-3603-60 | 00006360360 | 60 PACKET in 1 CARTON (0006-3603-60) / 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01)Marketed from Dec 20, 2013 | |
| 0006-3603-61 | 00006360361 | 60 PACKET in 1 CARTON (0006-3603-61) / 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01)Marketed from Nov 22, 2017 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Isentress
- Generic name (nonproprietary)
- raltegravir
- Active ingredients
- Raltegravir potassium — 100 mg/1
- Dosage form
- Granule, For suspension
- Route
- Oral
- Labeler
- Merck Sharp & Dohme LLCNDC labeler code 0006
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205786
- Marketing start
- Listing expires
- Other FDA classes
- HIV Integrase Inhibitors (Mechanism)
- Identifiers
- Product ID 0006-3603_70b9b593-db43-43ad-8808-a1c86c048145SPL ID 70b9b593-db43-43ad-8808-a1c86c048145SPL set ID 89a5ec53-d956-4329-8004-0f40f51c88a3RxCUI 744842, 744846, 1235588, 1235591, 1235593, 1235595, 1486838, 1486841, 1924313, 1924315UNII 43Y000U234UPC 0300060227615, 0300060473616, 0300063080019
- 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
N400006360360followed by a unit qualifier and the quantityPackage 00006-3603-60. 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: ISENTRESS and ISENTRESS HD 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: ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg ( 1 ). ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg ( 1 ). Adult Patients: ISENTRESS ® and ISENTRESS ® HD are indicated in combination with other antiretroviral agents …
Excerpt only. Read the full label for complete information.
About NDC 0006-3603
- What is NDC 0006-3603?
- 0006-3603 is the product NDC for Isentress (raltegravir), Raltegravir potassium 100 mg/1 granule, for suspension, listed with the FDA by Merck Sharp & Dohme LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Isentress (Raltegravir).
- What is the active ingredient?
- Raltegravir potassium.
- Who is the labeler?
- Merck Sharp & Dohme LLC, NDC labeler code 0006. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Isentress?
- 7 other product NDCs are listed under this name. See all Isentress NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Isentress products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Isentressraltegravir | Raltegravir potassium 600 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-3080 | 00006-3080-01 |
| Isentressraltegravir | Raltegravir potassium 100 mg/1 | Tablet, ChewableOral | Merck Sharp & Dohme LLC | 0006-0477 | 00006-0477-61 |
| Isentressraltegravir | Raltegravir potassium 25 mg/1 | Tablet, ChewableOral | Merck Sharp & Dohme LLC | 0006-0473 | 00006-0473-61 |
| Isentressraltegravir | Raltegravir potassium 400 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2113 | 68071-2113-06 |
| Isentressraltegravir | Raltegravir potassium 400 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1085 | 50090-1085-00 |
| Isentressraltegravir | Raltegravir potassium 400 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-0227 | 00006-0227-61 |
| Isentressraltegravir | Raltegravir potassium 400 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-777 | 71205-0777-0671205-0777-1471205-0777-30+2 more |