FDA.reportPublic FDA data

PIFELTRO

Product NDC
50090-6268
11-digit product format
500906268
Labeler code
50090
Product ID
50090-6268_82b1d205-8f81-4755-b34d-931352fa834b
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
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-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
ndc (product): 50090-6268
PIFELTRODORAVIRINEMerck Sharp & Dohme LLC76ce1f00-28c0-4314-bd2c-d473fe3d09702026-07-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 210806
application number: NDA210806

Additional Listing Data#

Finished product
Yes
Brand name base
PIFELTRO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DORAVIRINE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
913P6LK81MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2055760Internal RxNorm lookup
2055766Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff06e5cc-f47a-4779-816b-0e5b13e88a25Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8051c8a3-aee0-45a2-a236-8ee3f9e65f67Product name120181211
96181e45-8c55-4690-9c33-4c540d16a217Product name120181211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6268-0PIFELTRO30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6268-0EA - Each50090-6268174f25a6-1569-485e-a160-debbc012863212023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6268PIFELTRO (DORAVIRINE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 1 package rows20240103_ff06e5cc-f47a-4779-816b-0e5b13e88a25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2055760doravirine 100 MG Oral TabletPSNff06e5cc-f47a-4779-816b-0e5b13e88a253
2055766Pifeltro 100 MG Oral TabletPSNff06e5cc-f47a-4779-816b-0e5b13e88a253
2055766doravirine 100 MG Oral Tablet [Pifeltro]SBDff06e5cc-f47a-4779-816b-0e5b13e88a253
2055760doravirine 100 MG Oral TabletSCDff06e5cc-f47a-4779-816b-0e5b13e88a253
2055766Pifeltro 100 MG Oral TabletSYff06e5cc-f47a-4779-816b-0e5b13e88a253

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6268-05009062680030 TABLET, FILM COATED in 1 BOTTLE (50090-6268-0) 2022-12-130000-00-00NoNoCurrent