Home NDC 0006-3069 PIFELTRO
Product NDC 0006-3069
11-digit product format 000063069
Labeler code 0006
Product ID 0006-3069_20dc2455-4d48-4183-b1ad-29a2686dcd2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doravirine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Merck Sharp & Dohme LLC
Application NDA210806
Marketing category NDA
Marketing start 2018-07-20
Substance DORAVIRINE
Active strength 100 mg/1
Pharmacologic classes Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210806-001 PIFELTRO DORAVIRINE 100MG TABLET / ORAL RLD, RS 2018-08-30
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210806-001 8486975 2032-08-30 U-2394 Drug substance, Drug product 2018-09-17 N210806-001 8486975 2032-08-30 U-2630 Drug substance, Drug product 2018-09-17 N210806-001 8486975 2032-08-30 U-3308 Drug substance, Drug product 2018-09-17
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N210806-001 PIFELTRO 100MG TABLET / ORAL RLD, RS 2018-08-30 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N210806-001 8486975 2032-08-30 U-2630 Drug substance, Drug product 2018-09-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N210806-001 8486975 2032-08-30 U-2394 Drug substance, Drug product 2018-09-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N210806-001 8486975 2032-08-30 U-3308 Drug substance, Drug product 2018-09-17 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base PIFELTRO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DORAVIRINE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 913P6LK81M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2055760 Internal RxNorm lookup 2055766 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0006-3069-01 PIFELTRO 30 in 1 BOTTLE TABLET, FILM COATED 30 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-3069 PIFELTRO (DORAVIRINE) TABLET, FILM COATED [MERCK SHARP & DOHME LLC] 18 Current NDC, Legacy NDC, 1 package rows 20241122_76ce1f00-28c0-4314-bd2c-d473fe3d0970.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0006-3069-01 00006306901 30 TABLET, FILM COATED in 1 BOTTLE (0006-3069-01) 2018-07-20 0000-00-00 No No Current