Prescription drug · NDA
Delstrigo NDC 0006-5007
doravirine, lamivudine, and tenofovir disoproxil fumarate · Doravirine 100 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-5007-01 | 0000650070100006500701 | 30 TABLET, FILM COATED in 1 BOTTLE (0006-5007-01)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)
- Delstrigo
- Generic name (nonproprietary)
- doravirine, lamivudine, and tenofovir disoproxil fumarate
- Active ingredients
- Doravirine — 100 mg/1Lamivudine — 300 mg/1Tenofovir disoproxil fumarate — 300 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 210807
- Marketing start
- Listing expires
- Other FDA classes
- Non-Nucleoside Analog (EXT)Non-Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleosides (Chemical structure)
- Identifiers
- Product ID 0006-5007_246882d6-9ed0-452a-8da7-aa919a22b571SPL ID 246882d6-9ed0-452a-8da7-aa919a22b571SPL set ID cd1e9f84-607a-46d3-b01e-2736018d67b6RxCUI 2055813, 2055815UNII 913P6LK81M, 2T8Q726O95, OTT9J7900IUPC 0300065007014
- Pharmacologic class
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus 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
N400006500701followed by a unit qualifier and the quantityPackage 00006-5007-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
DELSTRIGO ® is indicated as a complete regimen 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 the individual components of DELSTRIGO [see Clinical Studies (14) ] . DELSTRIGO is a three-drug combination of doravirine (a non-nucleoside reverse transcriptase inhibitor [NNRTI]), lamivudine, and tenofovir disoproxil fumarate (both nucleoside analog…
Excerpt only. Read the full label for complete information.
About NDC 0006-5007
- What is NDC 0006-5007?
- 0006-5007 is the product NDC for Delstrigo, Doravirine 100 mg/1 + 2 more ingredients 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?
- Delstrigo (Doravirine, lamivudine, and tenofovir disoproxil fumarate).
- What is the active ingredient?
- Doravirine, Lamivudine, Tenofovir disoproxil fumarate.
- 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 Delstrigo?
- 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.