Home NDC 0006-3075 PREVYMIS
Product NDC 0006-3075
11-digit product format 000063075
Labeler code 0006
Product ID 0006-3075_282d792e-e2f2-4744-8526-4d18427c55cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LETERMOVIR
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Merck Sharp & Dohme LLC
Application NDA209939
Marketing category NDA
Marketing start 2017-11-08
Substance LETERMOVIR
Active strength 240 mg/1
Pharmacologic classes Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytomegalovirus DNA Terminase Complex Inhibitor [EPC], DNA Terminase Complex Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209939-001 PREVYMIS LETERMOVIR 240MG TABLET / ORAL RLD 2017-11-08 N209939-002 PREVYMIS LETERMOVIR 480MG TABLET / ORAL RLD, RS 2017-11-08
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 N209939-001 RE46791 2029-01-18 Drug substance, Drug product 2020-04-21 N209939-002 RE46791 2029-01-18 Drug substance, Drug product 2020-04-21
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 12 matching rows.
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 N209939-001 PREVYMIS 240MG TABLET / ORAL RLD 2017-11-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N209939-002 PREVYMIS 480MG TABLET / ORAL RLD, RS 2017-11-08 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 N209939-001 RE46791 2029-01-18 Drug substance, Drug product 2020-04-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N209939-002 RE46791 2029-01-18 Drug substance, Drug product 2020-04-21 a50c72e98297…
Observed Orange Book exclusivity history# 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base PREVYMIS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LETERMOVIR 240 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1H09Y5WO1F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 12 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1988652 Internal RxNorm lookup 1988657 Internal RxNorm lookup 1988660 Internal RxNorm lookup 1988661 Internal RxNorm lookup 1988666 Internal RxNorm lookup 1988671 Internal RxNorm lookup 1988673 Internal RxNorm lookup 1988675 Internal RxNorm lookup 2693185 Internal RxNorm lookup 2693189 Internal RxNorm lookup 2693191 Internal RxNorm lookup 2693193 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 0006-3075-01 PREVYMIS 7 in 1 DOSE PACK TABLET, FILM COATED 7 28 0006-3075-02 PREVYMIS 4 in 1 CARTON TABLET, FILM COATED 4 28 0006-3075-03 PREVYMIS 1 in 1 BLISTER PACK TABLET, FILM COATED 1 28 0006-3075-04 PREVYMIS 14 in 1 CARTON TABLET, FILM COATED 14 28
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-3075 PREVYMIS (LETERMOVIR) TABLET, FILM COATED PREVYMIS (LETERMOVIR) INJECTION, SOLUTION PREVYMIS (LETERMOVIR) PELLET [MERCK SHARP & DOHME LLC] 27 Current NDC, Legacy NDC, 4 package rows 20250215_1b49df80-be4f-47e0-a0b7-123f3e69395b.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0006-3075-01 00006307501 7 in 1 DOSE PACK Historical 0006-3075-02 00006307502 4 DOSE PACK in 1 CARTON (0006-3075-02) / 7 TABLET, FILM COATED in 1 DOSE PACK (0006-3075-01) 4 dose pack 2017-11-08 0000-00-00 No No Current 0006-3075-03 00006307503 1 in 1 BLISTER PACK Historical 0006-3075-04 00006307504 14 BLISTER PACK in 1 CARTON (0006-3075-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-3075-03) 14 blister pack 2017-11-08 0000-00-00 No No Current