Prescription drug · NDA
Dovato (Dolutegravir sodium and lamivudine) NDC 49702-246
Dolutegravir sodium 50 mg/1; Lamivudine 300 mg/1 · Tablet, Film coated · Oral · ViiV Healthcare Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49702-246-13 | 4970202461349702024613 | 30 TABLET, FILM COATED in 1 BOTTLE (49702-246-13)Marketed from Apr 8, 2019 | |
| 49702-246-33 | 4970202463349702024633 | 1 BLISTER PACK in 1 CARTON (49702-246-33) / 30 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 1, 2024 | |
| 49702-246-62 | 4970202466249702024662 | 1 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
N449702024613followed by a unit qualifier and the quantityPackage 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.
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.