NDC codes

FDA NDC Directory
Product NDC (as listed)49702-246Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49702-0246Add 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
49702-246-13497020246134970202461330 TABLET, FILM COATED in 1 BOTTLE (49702-246-13)Marketed from Apr 8, 2019
49702-246-3349702024633497020246331 BLISTER PACK in 1 CARTON (49702-246-33) / 30 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 1, 2024
49702-246-6249702024662497020246621 BLISTER PACK in 1 CARTON (49702-246-62) / 14 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 1, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Dovato
Generic name (nonproprietary)
dolutegravir sodium and lamivudine
Active ingredients
Dolutegravir sodium — 50 mg/1Lamivudine — 300 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
ViiV Healthcare CompanyNDC labeler code 49702
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 211994
Marketing start
Listing expires
Other FDA classes
HIV Integrase Inhibitors (Mechanism)Multidrug and Toxin Extrusion Transporter 1 Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)
Identifiers
Product ID 49702-246_9b88da25-ebce-49ae-8c8a-dcee6f465957SPL ID 9b88da25-ebce-49ae-8c8a-dcee6f465957SPL set ID 68e45422-43ed-4cfb-9356-fae88d14a53aRxCUI 2122519, 2122526UNII 1Q1V9V5WYQ, 2T8Q726O95
Pharmacologic class
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus Integrase Strand Transfer 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

N449702024613 followed by a unit qualifier and the quantity

Package 49702-0246-13. 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)

DOVATO is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or 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 treatment failure and no known substitutions associated with resistance to the individual components of DOVATO. DOVATO, a two-drug combination of dolutegravir (integrase strand transfer inhibitor [INSTI]) and lamivudine (nucleoside analogue reverse transcriptase inhibitor [NRTI]) is indicated as a complete regimen for …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 49702-246

What is NDC 49702-246?
49702-246 is the product NDC for Dovato, Dolutegravir sodium 50 mg/1; Lamivudine 300 mg/1 tablet, film coated, listed with the FDA by ViiV Healthcare Company. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dovato (Dolutegravir sodium and lamivudine).
What is the active ingredient?
Dolutegravir sodium, Lamivudine.
Who is the labeler?
ViiV Healthcare Company, NDC labeler code 49702. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dovato?
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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