Prescription drug · NDA
Rukobia (Fostemsavir tromethamine) NDC 49702-250
Fostemsavir tromethamine 600 mg/1 · Tablet, Film coated, Extended release · Oral · ViiV Healthcare Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49702-250-18 | 4970202501849702025018 | 1 BOTTLE in 1 CARTON (49702-250-18) / 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Jul 2, 2020 |
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)
- Rukobia
- Generic name (nonproprietary)
- fostemsavir tromethamine
- Active ingredients
- Fostemsavir tromethamine — 600 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- ViiV Healthcare CompanyNDC labeler code 49702
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212950
- Marketing start
- Listing expires
- Identifiers
- Product ID 49702-250_6c5f162a-40d2-4024-badd-6e80ec4641d7SPL ID 6c5f162a-40d2-4024-badd-6e80ec4641d7SPL set ID a21006b7-6d6f-4f06-81b4-17978756452bRxCUI 2380549, 2380551UNII 2X513P36U0
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
N449702025018followed by a unit qualifier and the quantityPackage 49702-0250-18. 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)
RUKOBIA, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations [see Clinical Studies ( 14 )]. RUKOBIA, a human immunodeficiency virus type 1 (HIV-1) gp120-directed attachment inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance,…
Excerpt only. Read the full label for complete information.
About NDC 49702-250
- What is NDC 49702-250?
- 49702-250 is the product NDC for Rukobia (fostemsavir tromethamine), Fostemsavir tromethamine 600 mg/1 tablet, film coated, extended release, listed with the FDA by ViiV Healthcare Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rukobia (Fostemsavir tromethamine).
- What is the active ingredient?
- Fostemsavir tromethamine.
- Who is the labeler?
- ViiV Healthcare Company, NDC labeler code 49702. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rukobia?
- 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.