FDA.reportPublic FDA data

Meropenem

Product NDC
63323-507
11-digit product format
633230507
Labeler code
63323
Product ID
63323-507_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
2011-10-14
Substance
MEROPENEM
Active strength
500 mg/10mL
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/10mL

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
63323-507-19Meropenem10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION1016
63323-507-21Meropenem10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1016
63323-507-01Meropenem10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION1015
63323-507-20Meropenem10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1015
63323-507-25Meropenem25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2511
63323-507-43Meropenem10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-507-01EA - Each63323-507321fad89-ec91-4ad9-b2ac-997a43e0700012022-02-07
63323-507-19EA - Each63323-5076a7006db-9032-4cd3-b56e-f212b63a972312026-02-05
63323-507-20EA - Each63323-507f953ac5f-8c3d-4763-872a-d6ddb14d6a0f12012-07-24
63323-507-21EA - Each63323-5079009ebdc-77de-4985-9030-c0d4ae27872812013-03-03
63323-507-25EA - Each63323-5072e82be56-fe76-48de-8880-577c544c7e5b12015-01-05

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
63323-507MEROPENEM (MEROPENEM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC ]16Current NDC, Legacy NDC, 2 package rows20210317_12714f80-d6e5-4453-b66c-62f57c16ddfc.zip
63323-507MEROPENEM (MEROPENEM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC ]15Current NDC, Legacy NDC, 2 package rows20210310_185181e3-c004-4d61-b992-5df94fe57a90.zip
63323-507MEROPENEM (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
63323-507-016332305070110 mL in 1 VIAL10 mlHistorical
63323-507-196332305071910 mL in 1 VIAL10 mlHistorical
63323-507-206332305072010 VIAL in 1 CARTON (63323-507-20) / 10 mL in 1 VIAL (63323-507-01) 10 vial2011-10-140000-00-00NoNoCurrent
63323-507-216332305072110 VIAL in 1 CARTON (63323-507-21) / 10 mL in 1 VIAL (63323-507-19) 10 vial2011-10-140000-00-00NoNoCurrent
63323-507-256332305072525 VIAL in 1 CARTON (63323-507-25) / 10 mL in 1 VIAL (63323-507-43) 25 vial2011-10-140000-00-00NoNoCurrent
63323-507-436332305074310 mL in 1 VIAL10 mlHistorical