Prescription drug · NDA
Pifeltro (Doravirine) NDC 0006-3069
Doravirine 100 mg/1 · Tablet, Film coated · Oral · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-3069-01 | 00006306901 | 30 TABLET, FILM COATED in 1 BOTTLE (0006-3069-01)Marketed from Jul 20, 2018 |
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)
- Pifeltro
- Generic name (nonproprietary)
- doravirine
- Active ingredients
- Doravirine — 100 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 210806
- Marketing start
- Listing expires
- Other FDA classes
- Non-Nucleoside Analog (EXT)Non-Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
- Identifiers
- Product ID 0006-3069_213c6c93-b2a7-43c1-a380-c3799a9343b0SPL ID 213c6c93-b2a7-43c1-a380-c3799a9343b0SPL set ID 76ce1f00-28c0-4314-bd2c-d473fe3d0970RxCUI 2055760, 2055766UNII 913P6LK81MUPC 0300063069014
- 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
N400006306901followed by a unit qualifier and the quantityPackage 00006-3069-01. 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)
PIFELTRO ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: with no prior antiretroviral treatment history; OR to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine [see Clinical Studies (14) ] . PIFELTRO, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pedi…
Excerpt only. Read the full label for complete information.
About NDC 0006-3069
- What is NDC 0006-3069?
- 0006-3069 is the product NDC for Pifeltro (doravirine), Doravirine 100 mg/1 tablet, film coated, listed with the FDA by Merck Sharp & Dohme LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pifeltro (Doravirine).
- What is the active ingredient?
- Doravirine.
- 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 Pifeltro?
- 1 other product NDC are listed under this name. See all Pifeltro NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pifeltro products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pifeltrodoravirine | Doravirine 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6268 | 50090-6268-00 |
Other NDCs under NDA 210806
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 |
|---|---|---|---|---|
| Pifeltrodoravirine | Doravirine 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6268 |