Meropenem

Product NDC
0143-9431
11-digit product format
001439431
Labeler code
0143
Product ID
0143-9431_9f2a2947-434c-4f43-aef4-b914cd862815
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meropenem
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA216424
Marketing category
ANDA
Marketing start
2024-09-01
Substance
MEROPENEM
Active strength
1 g/30mL
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/30mL

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
0143-9431-01Meropenem30 mL in 1 VIALINJECTION305
0143-9431-10Meropenem10 in 1 CARTONINJECTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9431-01EA - Each0143-943139bdcad7-321f-4a9a-a4d5-768588b4376812025-01-14
0143-9431-10EA - Each0143-94319d179540-eb53-4ce8-9cbc-00779fe99de412025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9431MEROPENEM INJECTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, 2 package rows20250312_d54fdbad-ca93-467c-92d7-c1bd88f3bbe3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722939meropenem 1 GM InjectionPSNd54fdbad-ca93-467c-92d7-c1bd88f3bbe35
1722934meropenem 500 MG InjectionPSNd54fdbad-ca93-467c-92d7-c1bd88f3bbe35
1722939meropenem 1000 MG InjectionSCDd54fdbad-ca93-467c-92d7-c1bd88f3bbe35
1722934meropenem 500 MG InjectionSCDd54fdbad-ca93-467c-92d7-c1bd88f3bbe35
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSYd54fdbad-ca93-467c-92d7-c1bd88f3bbe35
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSYd54fdbad-ca93-467c-92d7-c1bd88f3bbe35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9431-010014394310130 mL in 1 VIAL30 mlHistorical
0143-9431-100014394311010 VIAL in 1 CARTON (0143-9431-10) / 30 mL in 1 VIAL (0143-9431-01) 10 vial2024-09-01NoNoHistorical