NDC codes

FDA NDC Directory
Product NDC (as listed)0006-5007Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00006-5007Add 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
0006-5007-01000065007010000650070130 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

N400006500701 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in