Prescription drug · NDA
Idvynso (Doravirine, islatravir) NDC 0006-5092
Doravirine 100 mg/1; Islatravir anhydrous .25 mg/1 · Tablet, Film coated · Oral · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-5092-01 | 00006509201 | 30 TABLET, FILM COATED in 1 BOTTLE (0006-5092-01)Marketed from Apr 23, 2026 | |
| 0006-5092-59 | 00006509259 | 14 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
N400006509201followed by a unit qualifier and the quantityPackage 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.
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.