FDA.reportPublic FDA data

PIFELTRO

Product NDC
50090-6237
11-digit product format
500906237
Labeler code
50090
Product ID
50090-6237_bcf61557-ab36-4f94-b83c-9024c0cdb968
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doravirine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA210806
Marketing category
NDA
Marketing start
2018-07-20
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-6237DDiscontinued by firm2026-07-31
excluded packagepackage50090-623750090-6237-0DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N210806-001PIFELTRODORAVIRINE100MGTABLET / ORALRLD, RS2018-08-30

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N210806-00184869752032-08-30U-2394Drug substance, Drug product2018-09-17
N210806-00184869752032-08-30U-2630Drug substance, Drug product2018-09-17
N210806-00184869752032-08-30U-3308Drug substance, Drug product2018-09-17

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N210806-001PIFELTRO100MGTABLET / ORALRLD, RS2018-08-30a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N210806-00184869752032-08-30U-2630Drug substance, Drug product2018-09-17a50c72e98297…
2026-08-01 22:54:322026-06N210806-00184869752032-08-30U-2394Drug substance, Drug product2018-09-17a50c72e98297…
2026-08-01 22:54:322026-06N210806-00184869752032-08-30U-3308Drug substance, Drug product2018-09-17a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PIFELTRODORAVIRINEA-S Medication Solutionsff06e5cc-f47a-4779-816b-0e5b13e88a252026-07-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 210806
application number: NDA210806
PIFELTRODORAVIRINEMerck Sharp & Dohme LLC76ce1f00-28c0-4314-bd2c-d473fe3d09702026-07-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 210806
application number: NDA210806

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6237-0EA - Each50090-623717803e4f-964b-4b6f-86a9-11e21b75db6c12023-01-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6237-05009062370030 TABLET, FILM COATED in 1 BOTTLE (50090-6237-0) 2022-11-210000-00-00NoNoCurrent