pifeltro

Generic: doravirine

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

Drug Facts

Product Profile

Brand Name pifeltro
Generic Name doravirine
Labeler merck sharp & dohme llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

doravirine 100 mg/1

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-3069
Product ID 0006-3069_20dc2455-4d48-4183-b1ad-29a2686dcd2a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210806
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]
Mechanism of Action
non-nucleoside reverse transcriptase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00063069
Hyphenated Format 0006-3069

Supplemental Identifiers

RxCUI
2055760 2055766
UPC
0300063069014
UNII
913P6LK81M
NUI
N0000175463 N0000009948 N0000175460

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 pifeltro (source: ndc)
Generic Name doravirine (source: ndc)
Application Number NDA210806 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0006-3069-01)
source: ndc

Packages (1)

0006-3069-01 30 TABLET, FILM COATED in 1 BOTTLE (0006-3069-01)

Ingredients (1)

doravirine (100 mg/1)

Linked Drug Pages (1)

PIFELTRO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "20dc2455-4d48-4183-b1ad-29a2686dcd2a", "openfda": {"nui": ["N0000175463", "N0000009948", "N0000175460"], "upc": ["0300063069014"], "unii": ["913P6LK81M"], "rxcui": ["2055760", "2055766"], "spl_set_id": ["76ce1f00-28c0-4314-bd2c-d473fe3d0970"], "pharm_class_epc": ["Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Non-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 (0006-3069-01)", "package_ndc": "0006-3069-01", "marketing_start_date": "20180720"}], "brand_name": "PIFELTRO", "product_id": "0006-3069_20dc2455-4d48-4183-b1ad-29a2686dcd2a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Non-Nucleoside Analog [EXT]", "Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "0006-3069", "generic_name": "doravirine", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PIFELTRO", "active_ingredients": [{"name": "DORAVIRINE", "strength": "100 mg/1"}], "application_number": "NDA210806", "marketing_category": "NDA", "marketing_start_date": "20180720", "listing_expiration_date": "20261231"}