FDA.reportPublic FDA data

Meropenem

Product NDC
44567-402
11-digit product format
445670402
Labeler code
44567
Product ID
44567-402_65ec9fc3-b50a-481f-8fe4-011b0c848503
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meropenem
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
NDA215212
Marketing category
NDA
Marketing start
2023-09-08
Substance
MEROPENEM
Active strength
2 g/1
Pharmacologic classes
Carbapenems [CS], Penem Antibacterial [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEROPENEM2 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFV9J3JU8B1
Rxcui2664894

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
437602ae-8b0a-4f4e-8f97-eabd2e27845eProduct name620250305
407c0246-8bda-450d-8667-f622a350d05cProduct name120231023
b1a98f8c-7b20-4bc2-b772-289c5d0949a9Product name120171106
940e5686-419d-4429-a15d-7bf46e26b176Product name120150929

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44567-402-01Meropenem1 in 1 VIALINJECTION, POWDER, FOR SOLUTION14
44567-402-06Meropenem6 in 1 CARTONINJECTION, POWDER, FOR SOLUTION64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-402-01EA - Each44567-402b477f7b5-d167-4210-b692-ae789d4ae04712023-12-05
44567-402-06EA - Each44567-4024b397cbb-12cd-4460-bddb-38b37f9238f412023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-402MEROPENEM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]3Current NDC, 2 package rows20231103_240325ba-47a8-4ad1-bcab-6772069ee790.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2664894meropenem 2 GM InjectionPSN240325ba-47a8-4ad1-bcab-6772069ee7904
2664894meropenem 2000 MG InjectionSCD240325ba-47a8-4ad1-bcab-6772069ee7904
2664894meropenem 2 GM InjectionSY240325ba-47a8-4ad1-bcab-6772069ee7904

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
44567-402-01445670402011 in 1 VIALHistorical
44567-402-06445670402066 VIAL in 1 CARTON (44567-402-06) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (44567-402-01) 6 vial2023-09-08NoNoCurrent