Prescription drug · NDA
Isentress (Raltegravir) NDC 68071-2113
Raltegravir potassium 400 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-2113-6 | 68071211306 | 6 TABLET, FILM COATED in 1 BOTTLE (68071-2113-6)Marketed from Jan 25, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- NuCare Pharmaceuticals,Inc.NDC labeler code 68071
- 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 68071-2113_56861538-b6c8-1555-e063-6394a90ab5dcSPL ID 56861538-b6c8-1555-e063-6394a90ab5dcSPL set ID 46ef8e2e-ae63-6a3c-e054-00144ff8d46cRxCUI 744842, 744846UNII 43Y000U234UPC 0368071211368
- 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
N468071211306followed by a unit qualifier and the quantityPackage 68071-2113-06. 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)
ISENTRESS® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in patients 4 weeks of age and older. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response [see Clinical Studies (14) ] . ISENTRESS is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated: In combination with other antiretroviral agents for the treatment of HIV-1 infection in patients 4 weeks of age and older ( 1 ). The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response ( 14 ).
Excerpt only. Read the full label for complete information.
About NDC 68071-2113
- What is NDC 68071-2113?
- 68071-2113 is the product NDC for Isentress (raltegravir), Raltegravir potassium 400 mg/1 tablet, film coated, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, 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?
- NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 | Proficient Rx LP | 71205-777 | 71205-0777-0671205-0777-1471205-0777-30+2 more |
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 | Proficient Rx LP | 71205-777 |