Meropenem

Product NDC
72485-412
11-digit product format
724850412
Labeler code
72485
Product ID
72485-412_46333d96-9059-4cba-e063-6294a90ada4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meropenem
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
ARMAS PHARMACEUTICALS INC
Application
ANDA216154
Marketing category
ANDA
Marketing start
2023-05-31
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
72485-412-01Meropenem1 in 1 CARTONINJECTION13
72485-412-01Meropenem20 mL in 1 VIALINJECTION203
72485-412-10Meropenem20 mL in 1 VIALINJECTION203
72485-412-10Meropenem10 in 1 CARTONINJECTION103
72485-412-25Meropenem20 mL in 1 VIALINJECTION203
72485-412-25Meropenem25 in 1 CARTONINJECTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-412-01EA - Each72485-412ef46bef4-9eb1-4a62-ba5a-16f85c24754a12023-10-16
72485-412-10EA - Each72485-4121f6ecf66-5de8-478d-9530-dd907498af5212023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-412MEROPENEM INJECTION [ARMAS PHARMACEUTICALS INC]1Current NDC, 6 package rows20230810_e1122310-c3ed-42f1-b189-301c221ff1f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722939meropenem 1 GM InjectionPSNe1122310-c3ed-42f1-b189-301c221ff1f03
1722934meropenem 500 MG InjectionPSNe1122310-c3ed-42f1-b189-301c221ff1f03
1722939meropenem 1000 MG InjectionSCDe1122310-c3ed-42f1-b189-301c221ff1f03
1722934meropenem 500 MG InjectionSCDe1122310-c3ed-42f1-b189-301c221ff1f03
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSYe1122310-c3ed-42f1-b189-301c221ff1f03
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSYe1122310-c3ed-42f1-b189-301c221ff1f03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72485-412-01724850412011 VIAL in 1 CARTON (72485-412-01) / 20 mL in 1 VIAL1 vial2023-08-10NoNoHistorical
72485-412-107248504121010 VIAL in 1 CARTON (72485-412-10) / 20 mL in 1 VIAL10 vial2023-08-10NoNoHistorical
72485-412-257248504122525 VIAL in 1 CARTON (72485-412-25) / 20 mL in 1 VIAL25 vial2023-08-10NoNoHistorical