FDA.reportPublic FDA data

Meropenem

Product NDC
44567-401
11-digit product format
445670401
Labeler code
44567
Product ID
44567-401_b1a7606e-81b5-4e9e-be8c-b0e50b3cbde8
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
2020-01-09
Substance
MEROPENEM
Active strength
1 g/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
MEROPENEM1 g/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
44567-401-01Meropenem1 in 1 VIALINJECTION, POWDER, FOR SOLUTION15
44567-401-10Meropenem10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-401-01EA - Each44567-401e506ac05-45a8-4844-a184-66bf93b6737812020-04-20
44567-401-10EA - Each44567-401b64fa70c-cbac-45bc-8446-59f3fb8300cb12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-401MEROPENEM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]5Current NDC, Legacy NDC, 2 package rows20250228_74ff19b5-6156-4a27-affb-744b0ce1aeec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722939meropenem 1 GM InjectionPSN74ff19b5-6156-4a27-affb-744b0ce1aeec5
1722934meropenem 500 MG InjectionPSN74ff19b5-6156-4a27-affb-744b0ce1aeec5
1722939meropenem 1000 MG InjectionSCD74ff19b5-6156-4a27-affb-744b0ce1aeec5
1722934meropenem 500 MG InjectionSCD74ff19b5-6156-4a27-affb-744b0ce1aeec5
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSY74ff19b5-6156-4a27-affb-744b0ce1aeec5
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSY74ff19b5-6156-4a27-affb-744b0ce1aeec5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-401-01445670401011 in 1 VIALHistorical
44567-401-104456704011010 VIAL in 1 CARTON (44567-401-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (44567-401-01) 10 vial2020-01-090000-00-00NoNoCurrent