FDA.reportPublic FDA data

Meropenem

Product NDC
44567-145
11-digit product format
445670145
Labeler code
44567
Product ID
44567-145_174553b5-2586-46de-95d4-bc87f9e46e4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meropenem
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA210773
Marketing category
ANDA
Marketing start
2021-06-30
Substance
MEROPENEM
Active strength
500 mg/1
Pharmacologic classes
Carbapenems [CS], Penem Antibacterial [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Meropenem
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEROPENEM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFV9J3JU8B1
Rxcui1722934, 1722939

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
44567-145-01Meropenem1 in 1 VIALINJECTION, POWDER, FOR SOLUTION14
44567-145-10Meropenem10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-145-01EA - Each44567-145128ae891-f61c-44df-856b-8eb2b2ac5d7612022-06-06
44567-145-10EA - Each44567-145acde99b4-1134-45c1-b75f-fff7778120ee12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-145MEROPENEM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]4Current NDC, Legacy NDC, 2 package rows20250228_6520ae3d-e149-499c-8152-36f6ab861662.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722939meropenem 1 GM InjectionPSN6520ae3d-e149-499c-8152-36f6ab8616624
1722934meropenem 500 MG InjectionPSN6520ae3d-e149-499c-8152-36f6ab8616624
1722939meropenem 1000 MG InjectionSCD6520ae3d-e149-499c-8152-36f6ab8616624
1722934meropenem 500 MG InjectionSCD6520ae3d-e149-499c-8152-36f6ab8616624
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSY6520ae3d-e149-499c-8152-36f6ab8616624
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSY6520ae3d-e149-499c-8152-36f6ab8616624

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-145-01445670145011 in 1 VIALHistorical
44567-145-104456701451010 VIAL in 1 CARTON (44567-145-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (44567-145-01) 10 vial2021-06-300000-00-00NoNoCurrent