Home NDC 0006-5092-59 IDVYNSO
Product NDC 0006-5092
Requested package NDC 0006-5092-59
11-digit product format 000065092
Labeler code 0006
Product ID 0006-5092_36245cd8-5e98-408c-a2df-38f9642b0827
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doravirine, Islatravir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Merck Sharp & Dohme LLC
Application NDA216964
Marketing category NDA
Marketing start 2026-04-23
Substance DORAVIRINE; ISLATRAVIR ANHYDROUS
Active strength 100; .25 mg/1; 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N216964-001 IDVYNSO DORAVIRINE; ISLATRAVIR 100MG;0.25MG TABLET / ORAL RLD, RS 2026-04-20
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216964-001 7339053 2027-05-31 Drug substance 2026-05-19 N216964-001 8486975 2032-08-30 U-4527 Drug substance, Drug product 2026-05-19
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N216964-001 NCE 2031-04-20
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 2026-09-14 22:38:34 2026-08 N216964-001 IDVYNSO 100MG;0.25MG TABLET / ORAL RLD, RS 2026-04-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216964-001 IDVYNSO 100MG;0.25MG TABLET / ORAL RLD, RS 2026-04-20 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216964-001 IDVYNSO 100MG;0.25MG TABLET / ORAL RLD, RS 2026-04-20 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 2026-09-14 22:38:34 2026-08 N216964-001 7339053 2027-05-31 Drug substance 2026-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216964-001 8486975 2032-08-30 U-4527 Drug substance, Drug product 2026-05-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216964-001 7339053 2027-05-31 Drug substance 2026-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216964-001 8486975 2032-08-30 U-4527 Drug substance, Drug product 2026-05-19 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216964-001 7339053 2027-05-31 Drug substance 2026-05-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216964-001 8486975 2032-08-30 U-4527 Drug substance, Drug product 2026-05-19 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 N216964-001 NCE 2031-04-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216964-001 NCE 2031-04-20 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216964-001 NCE 2031-04-20 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base IDVYNSO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DORAVIRINE 100 mg/1 ISLATRAVIR ANHYDROUS .25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 913P6LK81M Internal UNII lookup QPQ082R25D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2741694 Internal RxNorm lookup 2741700 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 0006-5092-01 IDVYNSO 30 in 1 BOTTLE TABLET, FILM COATED 30 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0006-5092-59 00006509259 14 TABLET, FILM COATED in 1 BOTTLE (0006-5092-59) 2026-04-23 Yes No Current