FDA.reportPublic FDA data

MEROPENEM

Product NDC
44647-032
11-digit product format
446470032
Labeler code
44647
Product ID
44647-032_4462e33b-7723-b7b4-e063-6294a90a981a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MEROPENEM
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Savior Lifetec Corporation
Application
ANDA206086
Marketing category
ANDA
Marketing start
2016-04-19
Substance
MEROPENEM
Active strength
500 mg/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
MEROPENEM500 mg/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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44647-032-102025-12-03C16284748780-1f386c649-991c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MEROPENEM FOR INJECTION safely and effectively. See full prescribing information for MEROPENEM FOR INJECTION MEROPENEM for injection, for intravenous use Initial U.S. Approval:1996
44647-032-102023-01-30C16284748780-1f386c649-991c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MEROPENEM FOR INJECTION safely and effectively. See full prescribing information for MEROPENEM FOR INJECTION MEROPENEM for injection, for intravenous use Initial U.S. Approval:1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44647-032-01MEROPENEM20 mL in 1 VIALINJECTION205
44647-032-10MEROPENEM10 in 1 CARTONINJECTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44647-032MEROPENEM INJECTION [SAVIOR LIFETEC CORPORATION]2Current NDC, Legacy NDC, 2 package rows20160812_31dd2160-7dbd-51fa-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722939meropenem 1 GM InjectionPSN31dd2160-7dbd-51fa-e054-00144ff88e885
1722934meropenem 500 MG InjectionPSN31dd2160-7dbd-51fa-e054-00144ff88e885
1722939meropenem 1000 MG InjectionSCD31dd2160-7dbd-51fa-e054-00144ff88e885
1722934meropenem 500 MG InjectionSCD31dd2160-7dbd-51fa-e054-00144ff88e885
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSY31dd2160-7dbd-51fa-e054-00144ff88e885
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSY31dd2160-7dbd-51fa-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44647-032-014464700320120 mL in 1 VIAL20 mlHistorical
44647-032-104464700321010 VIAL in 1 CARTON (44647-032-10) / 20 mL in 1 VIAL (44647-032-01) 10 vial2016-04-190000-00-00NoNoCurrent