FDA.reportPublic FDA data

LAGEVRIO

Product NDC
0006-5055
Requested package NDC
0006-5055-07
11-digit product format
000065055
Labeler code
0006
Product ID
0006-5055_12940f6d-e61c-47aa-810e-8b2ad5ce3059
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
molnupiravir
Dosage form
CAPSULE
Route
ORAL
Labeler
Merck Sharp & Dohme LLC
Marketing category
EMERGENCY USE AUTHORIZATION
Marketing start
2021-12-23
Marketing end
0000-00-00
Substance
MOLNUPIRAVIR
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0006-50550006-5055-07IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-5055-06LAGEVRIO40 in 1 BOTTLE, PLASTICCAPSULE4027
0006-5055-07LAGEVRIO40 in 1 BOTTLE, PLASTICCAPSULE4027
0006-5055-09LAGEVRIO40 in 1 BOTTLE, PLASTICCAPSULE4027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-5055-06EA - Each0006-50553e26b282-2858-4738-8201-5d27fc99ec5c12022-01-06
0006-5055-07EA - Each0006-5055b57bc5a6-fcd4-4830-bfe2-811980d6b35512023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-5055LAGEVRIO (MOLNUPIRAVIR) CAPSULE [MERCK SHARP & DOHME LLC]24Legacy NDC, 3 package rows20240713_1b0da643-ab23-4a0b-a9ec-a434522446d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2603740Lagevrio 200 MG Oral Capsule (EUA)PSN1b0da643-ab23-4a0b-a9ec-a434522446d027
2587906molnupiravir 200 MG Oral Capsule (EUA)PSN1b0da643-ab23-4a0b-a9ec-a434522446d027
2603740molnupiravir 200 MG Oral Capsule [Lagevrio]SBD1b0da643-ab23-4a0b-a9ec-a434522446d027
2587906molnupiravir 200 MG Oral CapsuleSCD1b0da643-ab23-4a0b-a9ec-a434522446d027
2603740Lagevrio 200 MG Oral Capsule (EUA)SY1b0da643-ab23-4a0b-a9ec-a434522446d027

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-5055-070000650550740 CAPSULE in 1 BOTTLE, PLASTIC (0006-5055-07) 40 capsule2021-12-230000-00-00NoNoCurrent