Meropenem

Product NDC
55150-208
11-digit product format
551500208
Labeler code
55150
Product ID
55150-208_5b3b7e4e-2c4b-433f-b422-8204068e1539
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meropenem
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA205835
Marketing category
ANDA
Marketing start
2017-03-27
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
55150-208-30Meropenem1 in 1 VIALINJECTION, POWDER, FOR SOLUTION110
55150-208-30Meropenem10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-208-30EA - Each55150-208f67ce4bd-6999-43be-a9ca-cec614f7d39f12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-208MEROPENEM INJECTION, POWDER, FOR SOLUTION [EUGIA US LLC]9Current NDC, Legacy NDC, 2 package rows20241228_bf1d3433-9e3f-40a0-8bff-c8ceaa8bab7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722939meropenem 1 GM InjectionPSNbf1d3433-9e3f-40a0-8bff-c8ceaa8bab7c10
1722934meropenem 500 MG InjectionPSNbf1d3433-9e3f-40a0-8bff-c8ceaa8bab7c10
1722939meropenem 1000 MG InjectionSCDbf1d3433-9e3f-40a0-8bff-c8ceaa8bab7c10
1722934meropenem 500 MG InjectionSCDbf1d3433-9e3f-40a0-8bff-c8ceaa8bab7c10
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSYbf1d3433-9e3f-40a0-8bff-c8ceaa8bab7c10
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSYbf1d3433-9e3f-40a0-8bff-c8ceaa8bab7c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-208-305515002083010 VIAL in 1 CARTON (55150-208-30) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL10 vial2017-03-270000-00-00NoNoCurrent