NDC codes

FDA NDC Directory
Product NDC (as listed)0006-5092Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00006-5092Add 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
0006-5092-010000650920130 TABLET, FILM COATED in 1 BOTTLE (0006-5092-01)Marketed from Apr 23, 2026
0006-5092-590000650925914 TABLET, FILM COATED in 1 BOTTLE (0006-5092-59)Marketed from Apr 23, 2026 · Sample package

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Idvynso
Generic name (nonproprietary)
doravirine, islatravir
Active ingredients
Doravirine — 100 mg/1Islatravir anhydrous — .25 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Merck Sharp & Dohme LLCNDC labeler code 0006
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 216964
Marketing start
Listing expires
Other FDA classes
Non-Nucleoside Analog (EXT)Non-Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers
Product ID 0006-5092_36245cd8-5e98-408c-a2df-38f9642b0827SPL ID 36245cd8-5e98-408c-a2df-38f9642b0827SPL set ID 11aaeb53-9848-433c-be7f-db8a5bc0b26fRxCUI 2741694, 2741700UNII 913P6LK81M, QPQ082R25DUPC 0300065092010
Pharmacologic class
Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase 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

N400006509201 followed by a unit qualifier and the quantity

Package 00006-5092-01. 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)

IDVYNSO™ is indicated as a complete two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine [see Microbiology (12.4) and Clinical Studies (14) ]. IDVYNSO is a two-drug combination of doravirine, a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), and islatravir, a nucleoside analog reverse transcriptase inhibitor (NRTI), and is indicated as a complete regimen for the…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0006-5092

What is NDC 0006-5092?
0006-5092 is the product NDC for Idvynso, Doravirine 100 mg/1; Islatravir anhydrous .25 mg/1 tablet, film coated, listed with the FDA by Merck Sharp & Dohme LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Idvynso (Doravirine, Islatravir).
What is the active ingredient?
Doravirine, Islatravir anhydrous.
Who is the labeler?
Merck Sharp & Dohme LLC, NDC labeler code 0006. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Idvynso?
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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