PREVYMIS

Product NDC
0006-3076
11-digit product format
000063076
Labeler code
0006
Product ID
0006-3076_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
480 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LETERMOVIR480 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1H09Y5WO1F
Rxcui1988652, 1988657, 1988660, 1988661, 1988666, 1988671, 1988673, 1988675, 2693185, 2693189, 2693191, 2693193

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33e56060-0089-4cc9-bb16-d2fc207d0bfdProduct name220250318
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-3076-01PREVYMIS7 in 1 DOSE PACKTABLET, FILM COATED728
0006-3076-02PREVYMIS4 in 1 CARTONTABLET, FILM COATED428
0006-3076-03PREVYMIS1 in 1 BLISTER PACKTABLET, FILM COATED128
0006-3076-04PREVYMIS14 in 1 CARTONTABLET, FILM COATED1428

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-3076-01EA - Each0006-30769db5294a-063e-4a9e-9afc-79ba563b3ee112018-03-08
0006-3076-02EA - Each0006-307622c72308-37ef-42e4-9ffa-0a9bd7eb884912018-01-12
0006-3076-03EA - Each0006-307672b3c957-f2db-4dac-8010-ca5a4011c63912018-04-19
0006-3076-04EA - Each0006-307647ffe391-848b-417d-89d6-8f243e90cc4812017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-3076PREVYMIS (LETERMOVIR) TABLET, FILM COATED PREVYMIS (LETERMOVIR) INJECTION, SOLUTION PREVYMIS (LETERMOVIR) PELLET [MERCK SHARP & DOHME LLC]27Current NDC, Legacy NDC, 4 package rows20250215_1b49df80-be4f-47e0-a0b7-123f3e69395b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2693191letermovir 120 MG Oral PelletPSN1b49df80-be4f-47e0-a0b7-123f3e69395b28
2693185letermovir 20 MG Oral PelletPSN1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988652letermovir 240 MG in 12 ML InjectionPSN1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988666letermovir 240 MG Oral TabletPSN1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988660letermovir 480 MG in 24 ML InjectionPSN1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988673letermovir 480 MG Oral TabletPSN1b49df80-be4f-47e0-a0b7-123f3e69395b28
2693193PREVYMIS 120 MG Oral PelletPSN1b49df80-be4f-47e0-a0b7-123f3e69395b28
2693189PREVYMIS 20 MG Oral PelletPSN1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988657PREVYMIS 240 MG in 12 ML InjectionPSN1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988671PREVYMIS 240 MG Oral TabletPSN1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988661Prevymis 480 MG in 24 ML InjectionPSN1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988675PREVYMIS 480 MG Oral TabletPSN1b49df80-be4f-47e0-a0b7-123f3e69395b28
198865712 ML letermovir 20 MG/ML Injection [Prevymis]SBD1b49df80-be4f-47e0-a0b7-123f3e69395b28
198866124 ML letermovir 20 MG/ML Injection [Prevymis]SBD1b49df80-be4f-47e0-a0b7-123f3e69395b28
2693193letermovir 120 MG Oral Pellet [Prevymis]SBD1b49df80-be4f-47e0-a0b7-123f3e69395b28
2693189letermovir 20 MG Oral Pellet [Prevymis]SBD1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988671letermovir 240 MG Oral Tablet [Prevymis]SBD1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988675letermovir 480 MG Oral Tablet [Prevymis]SBD1b49df80-be4f-47e0-a0b7-123f3e69395b28
198865212 ML letermovir 20 MG/ML InjectionSCD1b49df80-be4f-47e0-a0b7-123f3e69395b28
198866024 ML letermovir 20 MG/ML InjectionSCD1b49df80-be4f-47e0-a0b7-123f3e69395b28
2693191letermovir 120 MG Oral PelletSCD1b49df80-be4f-47e0-a0b7-123f3e69395b28
2693185letermovir 20 MG Oral PelletSCD1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988666letermovir 240 MG Oral TabletSCD1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988673letermovir 480 MG Oral TabletSCD1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988652letermovir 20 MG/ML per 12 ML InjectionSY1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988660letermovir 20 MG/ML per 24 ML InjectionSY1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988652letermovir 240 MG per 12 ML InjectionSY1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988660letermovir 480 MG per 24 ML InjectionSY1b49df80-be4f-47e0-a0b7-123f3e69395b28
2693193Prevymis 120 MG Oral PelletSY1b49df80-be4f-47e0-a0b7-123f3e69395b28
2693189Prevymis 20 MG Oral PelletSY1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988657Prevymis 20 MG/ML per 12 ML InjectionSY1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988661Prevymis 20 MG/ML per 24 ML InjectionSY1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988671Prevymis 240 MG Oral TabletSY1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988657Prevymis 240 MG per 12 ML InjectionSY1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988675Prevymis 480 MG Oral TabletSY1b49df80-be4f-47e0-a0b7-123f3e69395b28
1988661Prevymis 480 MG per 24 ML InjectionSY1b49df80-be4f-47e0-a0b7-123f3e69395b28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-3076-01000063076017 in 1 DOSE PACKHistorical
0006-3076-02000063076024 DOSE PACK in 1 CARTON (0006-3076-02) / 7 TABLET, FILM COATED in 1 DOSE PACK (0006-3076-01) 4 dose pack2017-11-080000-00-00NoNoCurrent
0006-3076-03000063076031 in 1 BLISTER PACKHistorical
0006-3076-040000630760414 BLISTER PACK in 1 CARTON (0006-3076-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-3076-03) 14 blister pack2017-11-080000-00-00NoNoCurrent