FDA.reportPublic FDA data

Meropenem

Product NDC
0409-3412
11-digit product format
004093412
Labeler code
0409
Product ID
0409-3412_2ad24c61-4908-4053-997a-9d0a9e6810dc
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
2022-12-06
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
0409-3412-01Meropenem20 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION203
0409-3412-10Meropenem10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-3412-01EA - Each0409-341249b0c34d-3928-40ac-9d31-913dca7def4f12023-01-09
0409-3412-10EA - Each0409-34121cecb5c5-fe89-4220-95a1-fe0aff50c5ac12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-3412MEROPENEM INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC.]3Current NDC, Legacy NDC, 2 package rows20241108_e9b6555f-20a1-4415-bb80-3d034cfab95b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722939meropenem 1 GM InjectionPSNe9b6555f-20a1-4415-bb80-3d034cfab95b3
1722934meropenem 500 MG InjectionPSNe9b6555f-20a1-4415-bb80-3d034cfab95b3
1722939meropenem 1000 MG InjectionSCDe9b6555f-20a1-4415-bb80-3d034cfab95b3
1722934meropenem 500 MG InjectionSCDe9b6555f-20a1-4415-bb80-3d034cfab95b3
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSYe9b6555f-20a1-4415-bb80-3d034cfab95b3
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSYe9b6555f-20a1-4415-bb80-3d034cfab95b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-3412-010040934120120 mL in 1 VIAL20 mlHistorical
0409-3412-100040934121010 VIAL in 1 CARTON (0409-3412-10) / 20 mL in 1 VIAL (0409-3412-01) 10 vial2022-12-060000-00-00NoNoCurrent