Prescription drug · NDA
Isentress (Raltegravir) NDC 71205-777
Raltegravir potassium 400 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-777-06 | 71205077706 | 6 TABLET, FILM COATED in 1 BOTTLE (71205-777-06)Marketed from Oct 3, 2024 | |
| 71205-777-14 | 71205077714 | 14 TABLET, FILM COATED in 1 BOTTLE (71205-777-14)Marketed from Mar 15, 2023 | |
| 71205-777-30 | 71205077730 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-777-30)Marketed from Mar 15, 2023 | |
| 71205-777-60 | 71205077760 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-777-60)Marketed from Mar 15, 2023 | |
| 71205-777-90 | 71205077790 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-777-90)Marketed from Mar 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)
- Isentress
- Generic name (nonproprietary)
- raltegravir
- Active ingredients
- Raltegravir potassium — 400 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022145
- Marketing start
- Listing expires
- Other FDA classes
- HIV Integrase Inhibitors (Mechanism)
- Identifiers
- Product ID 71205-777_4cb3ef64-0fec-45c7-9c7f-5cca90c7a517SPL ID 4cb3ef64-0fec-45c7-9c7f-5cca90c7a517SPL set ID ccc6f2f9-696f-4ef9-bb4c-e0198d957b0bRxCUI 744842, 744846UNII 43Y000U234UPC 0371205777142
- 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
N471205077706followed by a unit qualifier and the quantityPackage 71205-0777-06. 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 71205-777
- What is NDC 71205-777?
- 71205-777 is the product NDC for Isentress (raltegravir), Raltegravir potassium 400 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 5 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?
- Proficient Rx LP, NDC labeler code 71205. 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 | Granule, For suspensionOral | Merck Sharp & Dohme LLC | 0006-3603 | 00006-3603-6000006-3603-61 |
| Isentressraltegravir | Raltegravir potassium 25 mg/1 | Tablet, ChewableOral | Merck Sharp & Dohme LLC | 0006-0473 | 00006-0473-61 |
| Isentressraltegravir | Raltegravir potassium 100 mg/1 | Tablet, ChewableOral | Merck Sharp & Dohme LLC | 0006-0477 | 00006-0477-61 |
| 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 | A-S Medication Solutions | 50090-1085 | 50090-1085-00 |
| Isentressraltegravir | Raltegravir potassium 400 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2113 | 68071-2113-06 |
Other NDCs under NDA 022145
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 |
|---|---|---|---|---|
| Isentressraltegravir | Raltegravir potassium 400 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-0227 |
| Isentressraltegravir | Raltegravir potassium 600 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-3080 |
| Isentressraltegravir | Raltegravir potassium 400 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1085 |
| Isentressraltegravir | Raltegravir potassium 400 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2113 |