FDA.reportPublic FDA data

Meropenem

Product NDC
63323-508
11-digit product format
633230508
Labeler code
63323
Product ID
63323-508_6e7f961a-7766-4426-8aa4-096bfba99e56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meropenem
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA091404
Marketing category
ANDA
Marketing start
2011-10-26
Substance
MEROPENEM
Active strength
1 g/20mL
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/20mL

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
63323-508-21Meropenem20 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION2016
63323-508-31Meropenem10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1016
63323-508-01Meropenem20 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION2015
63323-508-30Meropenem10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1015
63323-508-25Meropenem25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2511
63323-508-45Meropenem20 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION2011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-508-01EA - Each63323-5086d12e068-d73e-44ef-a6a1-6e3c72d9875c12021-09-07
63323-508-21EA - Each63323-5086c26f88d-9008-4dcc-99fc-918eaad44c9c12025-08-11
63323-508-25EA - Each63323-5088bcecc6e-1ea7-449b-8f80-9a05767f442a12015-01-05
63323-508-30EA - Each63323-508ca5ad3e0-e93b-4729-8e7b-347c6797869f12012-07-24
63323-508-31EA - Each63323-5088c633b01-bf77-42bb-808b-e1563504122212013-03-03
63323-508-45EA - Each63323-508bf89449d-3a53-46bb-b81b-8674c866e28712022-04-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEROPENEMACTIVE INGREDIENTFV9J3JU8B1MEROPENEM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]8
MEROPENEM ANHYDROUSACTIVE MOIETYYOP6PX0BAOMEROPENEM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]8
MEROPENEMACTIVE INGREDIENTFV9J3JU8B1MEROPENEM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]5
MEROPENEM ANHYDROUSACTIVE MOIETYYOP6PX0BAOMEROPENEM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]5
MEROPENEMACTIVE INGREDIENTFV9J3JU8B1MEROPENEM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
MEROPENEM ANHYDROUSACTIVE MOIETYYOP6PX0BAOMEROPENEM INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-508MEROPENEM (MEROPENEM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC ]16Current NDC, Legacy NDC, 2 package rows20210317_12714f80-d6e5-4453-b66c-62f57c16ddfc.zip
63323-508MEROPENEM (MEROPENEM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC ]15Current NDC, Legacy NDC, 2 package rows20210310_185181e3-c004-4d61-b992-5df94fe57a90.zip
63323-508MEROPENEM (MEROPENEM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]11Current NDC, Legacy NDC, 2 package rows20210316_7a68d899-2678-43a9-a9c1-ef8f916b562f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722939meropenem 1 GM InjectionPSN12714f80-d6e5-4453-b66c-62f57c16ddfc16
1722934meropenem 500 MG InjectionPSN12714f80-d6e5-4453-b66c-62f57c16ddfc16
1722939meropenem 1000 MG InjectionSCD12714f80-d6e5-4453-b66c-62f57c16ddfc16
1722934meropenem 500 MG InjectionSCD12714f80-d6e5-4453-b66c-62f57c16ddfc16
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSY12714f80-d6e5-4453-b66c-62f57c16ddfc16
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSY12714f80-d6e5-4453-b66c-62f57c16ddfc16
1722939meropenem 1 GM InjectionPSN185181e3-c004-4d61-b992-5df94fe57a9015
1722934meropenem 500 MG InjectionPSN185181e3-c004-4d61-b992-5df94fe57a9015
1722939meropenem 1000 MG InjectionSCD185181e3-c004-4d61-b992-5df94fe57a9015
1722934meropenem 500 MG InjectionSCD185181e3-c004-4d61-b992-5df94fe57a9015
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSY185181e3-c004-4d61-b992-5df94fe57a9015
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSY185181e3-c004-4d61-b992-5df94fe57a9015
1722939meropenem 1 GM InjectionPSN7a68d899-2678-43a9-a9c1-ef8f916b562f11
1722934meropenem 500 MG InjectionPSN7a68d899-2678-43a9-a9c1-ef8f916b562f11
1722939meropenem 1000 MG InjectionSCD7a68d899-2678-43a9-a9c1-ef8f916b562f11
1722934meropenem 500 MG InjectionSCD7a68d899-2678-43a9-a9c1-ef8f916b562f11
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSY7a68d899-2678-43a9-a9c1-ef8f916b562f11
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSY7a68d899-2678-43a9-a9c1-ef8f916b562f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-508-016332305080120 mL in 1 VIAL20 mlHistorical
63323-508-216332305082120 mL in 1 VIAL20 mlHistorical
63323-508-256332305082525 VIAL in 1 CARTON (63323-508-25) / 20 mL in 1 VIAL (63323-508-45) 25 vial2011-10-260000-00-00NoNoCurrent
63323-508-306332305083010 VIAL in 1 CARTON (63323-508-30) / 20 mL in 1 VIAL (63323-508-01) 10 vial2011-10-260000-00-00NoNoCurrent
63323-508-316332305083110 VIAL in 1 CARTON (63323-508-31) / 20 mL in 1 VIAL (63323-508-21) 10 vial2011-10-260000-00-00NoNoCurrent
63323-508-456332305084520 mL in 1 VIAL20 mlHistorical