FDA.reportPublic FDA data

Meropenem

Product NDC
0409-1391
11-digit product format
004091391
Labeler code
0409
Product ID
0409-1391_6bd78500-6717-4df3-86d4-23cba124547e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meropenem
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA091404
Marketing category
ANDA
Marketing start
2019-10-09
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
0409-1391-21Meropenem20 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION207
0409-1391-22Meropenem10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1391-21EA - Each0409-1391e585938d-28f1-4078-a24d-cc2a06f8397812019-11-12
0409-1391-22EA - Each0409-139127b545cb-a947-40e7-af69-dffbaeed572d12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1391MEROPENEM INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC.]7Current NDC, Legacy NDC, 2 package rows20241108_092ebd9b-77a0-4877-afc3-dd8211730f71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722939meropenem 1 GM InjectionPSN092ebd9b-77a0-4877-afc3-dd8211730f717
1722934meropenem 500 MG InjectionPSN092ebd9b-77a0-4877-afc3-dd8211730f717
1722939meropenem 1000 MG InjectionSCD092ebd9b-77a0-4877-afc3-dd8211730f717
1722934meropenem 500 MG InjectionSCD092ebd9b-77a0-4877-afc3-dd8211730f717
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSY092ebd9b-77a0-4877-afc3-dd8211730f717
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSY092ebd9b-77a0-4877-afc3-dd8211730f717

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1391-210040913912120 mL in 1 VIAL20 mlHistorical
0409-1391-220040913912210 VIAL in 1 CARTON (0409-1391-22) / 20 mL in 1 VIAL (0409-1391-21) 10 vial2019-10-090000-00-00NoNoCurrent