Prescription drug · NDA
Isentress (Raltegravir) NDC 50090-1085
Raltegravir potassium 400 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-1085-0 | 50090108500 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-1085-0)Marketed from Nov 28, 2014 |
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
- A-S Medication SolutionsNDC labeler code 50090
- 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 50090-1085_03efaa04-a8b6-47a3-850c-34c312f3c7a6SPL ID 03efaa04-a8b6-47a3-850c-34c312f3c7a6
- 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
N450090108500followed by a unit qualifier and the quantityPackage 50090-1085-00. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 50090-1085
- What is NDC 50090-1085?
- 50090-1085 is the product NDC for Isentress (raltegravir), Raltegravir potassium 400 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. 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?
- A-S Medication Solutions, NDC labeler code 50090. 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 | NuCare Pharmaceuticals,Inc. | 68071-2113 | 68071-2113-06 |
| 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 | NuCare Pharmaceuticals,Inc. | 68071-2113 |
| Isentressraltegravir | Raltegravir potassium 400 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-777 |