dovato

Generic: dolutegravir sodium and lamivudine

Labeler: viiv healthcare company
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name dovato
Generic Name dolutegravir sodium and lamivudine
Labeler viiv healthcare company
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

dolutegravir sodium 50 mg/1, lamivudine 300 mg/1

Manufacturer
ViiV Healthcare Company

Identifiers & Regulatory

Product NDC 49702-246
Product ID 49702-246_9b88da25-ebce-49ae-8c8a-dcee6f465957
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211994
Listing Expiration 2027-12-31
Marketing Start 2019-04-08

Pharmacologic Class

Established (EPC)
hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc] human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]
Mechanism of Action
nucleoside reverse transcriptase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49702246
Hyphenated Format 49702-246

Supplemental Identifiers

RxCUI
2122519 2122526
UNII
1Q1V9V5WYQ 2T8Q726O95
NUI
N0000175656 N0000175462 N0000009947

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dovato (source: ndc)
Generic Name dolutegravir sodium and lamivudine (source: ndc)
Application Number NDA211994 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (49702-246-13)
  • 1 BLISTER PACK in 1 CARTON (49702-246-33) / 30 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (49702-246-62) / 14 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

49702-246-13 30 TABLET, FILM COATED in 1 BOTTLE (49702-246-13) 49702-246-33 1 BLISTER PACK in 1 CARTON (49702-246-33) / 30 TABLET, FILM COATED in 1 BLISTER PACK 49702-246-62 1 BLISTER PACK in 1 CARTON (49702-246-62) / 14 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (2)

dolutegravir sodium (50 mg/1) lamivudine (300 mg/1)

Linked Drug Pages (1)

Dovato ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9b88da25-ebce-49ae-8c8a-dcee6f465957", "openfda": {"nui": ["N0000175656", "N0000175462", "N0000009947"], "unii": ["1Q1V9V5WYQ", "2T8Q726O95"], "rxcui": ["2122519", "2122526"], "spl_set_id": ["68e45422-43ed-4cfb-9356-fae88d14a53a"], "pharm_class_epc": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["ViiV Healthcare Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (49702-246-13)", "package_ndc": "49702-246-13", "marketing_start_date": "20190408"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (49702-246-33)  / 30 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "49702-246-33", "marketing_start_date": "20240101"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (49702-246-62)  / 14 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "49702-246-62", "marketing_start_date": "20240101"}], "brand_name": "Dovato", "product_id": "49702-246_9b88da25-ebce-49ae-8c8a-dcee6f465957", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HIV Integrase Inhibitors [MoA]", "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "product_ndc": "49702-246", "generic_name": "dolutegravir sodium and lamivudine", "labeler_name": "ViiV Healthcare Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dovato", "active_ingredients": [{"name": "DOLUTEGRAVIR SODIUM", "strength": "50 mg/1"}, {"name": "LAMIVUDINE", "strength": "300 mg/1"}], "application_number": "NDA211994", "marketing_category": "NDA", "marketing_start_date": "20190408", "listing_expiration_date": "20271231"}