delstrigo

Generic: doravirine, lamivudine, and tenofovir disoproxil fumarate

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name delstrigo
Generic Name doravirine, lamivudine, and tenofovir disoproxil fumarate
Labeler merck sharp & dohme llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

doravirine 100 mg/1, lamivudine 300 mg/1, tenofovir disoproxil fumarate 300 mg/1

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-5007
Product ID 0006-5007_237e7245-b6e8-40df-8d66-4bb122136834
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210807
Listing Expiration 2026-12-31
Marketing Start 2018-07-20

Pharmacologic Class

Established (EPC)
human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitor [epc] hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc] human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]
Mechanism of Action
non-nucleoside reverse transcriptase inhibitors [moa] nucleoside reverse transcriptase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00065007
Hyphenated Format 0006-5007

Supplemental Identifiers

RxCUI
2055813 2055815
UPC
0300065007014
UNII
913P6LK81M 2T8Q726O95 OTT9J7900I
NUI
N0000175463 N0000009948 N0000175460 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 delstrigo (source: ndc)
Generic Name doravirine, lamivudine, and tenofovir disoproxil fumarate (source: ndc)
Application Number NDA210807 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0006-5007-01)
source: ndc

Packages (1)

0006-5007-01 30 TABLET, FILM COATED in 1 BOTTLE (0006-5007-01)

Ingredients (3)

doravirine (100 mg/1) lamivudine (300 mg/1) tenofovir disoproxil fumarate (300 mg/1)

Linked Drug Pages (1)

DELSTRIGO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "237e7245-b6e8-40df-8d66-4bb122136834", "openfda": {"nui": ["N0000175463", "N0000009948", "N0000175460", "N0000175656", "N0000175462", "N0000009947"], "upc": ["0300065007014"], "unii": ["913P6LK81M", "2T8Q726O95", "OTT9J7900I"], "rxcui": ["2055813", "2055815"], "spl_set_id": ["cd1e9f84-607a-46d3-b01e-2736018d67b6"], "pharm_class_epc": ["Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0006-5007-01)", "package_ndc": "0006-5007-01", "marketing_start_date": "20180720"}], "brand_name": "DELSTRIGO", "product_id": "0006-5007_237e7245-b6e8-40df-8d66-4bb122136834", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Non-Nucleoside Analog [EXT]", "Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleosides [CS]"], "product_ndc": "0006-5007", "generic_name": "doravirine, lamivudine, and tenofovir disoproxil fumarate", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DELSTRIGO", "active_ingredients": [{"name": "DORAVIRINE", "strength": "100 mg/1"}, {"name": "LAMIVUDINE", "strength": "300 mg/1"}, {"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "300 mg/1"}], "application_number": "NDA210807", "marketing_category": "NDA", "marketing_start_date": "20180720", "listing_expiration_date": "20261231"}