NDC codes

FDA NDC Directory
Product NDC (as listed)49702-250Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49702-0250Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
49702-250-1849702025018497020250181 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

N449702025018 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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