FDA.reportPublic FDA data

Meropenem

Product NDC
68001-323
11-digit product format
680010323
Labeler code
68001
Product ID
68001-323_45bbbbfc-a4d7-c7ed-e063-6294a90aca41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meropenem
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA205883
Marketing category
ANDA
Marketing start
2017-04-30
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-323-29Meropenem20 mL in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION207
68001-323-31Meropenem10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-323-29EA - Each68001-323579d1b0f-a272-4dc5-8dfd-7e24d8a7b23412017-07-07
68001-323-31EA - Each68001-3233d3941d3-627e-4077-8a4b-56084935493112017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-323MEROPENEM INJECTION, POWDER, FOR SOLUTION [BLUEPOINT LABORATORIES]6Current NDC, Legacy NDC, 2 package rows20191023_ca5f501c-6520-4d09-aae2-4f5db74d468f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722939meropenem 1 GM InjectionPSNca5f501c-6520-4d09-aae2-4f5db74d468f7
1722934meropenem 500 MG InjectionPSNca5f501c-6520-4d09-aae2-4f5db74d468f7
1722939meropenem 1000 MG InjectionSCDca5f501c-6520-4d09-aae2-4f5db74d468f7
1722934meropenem 500 MG InjectionSCDca5f501c-6520-4d09-aae2-4f5db74d468f7
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSYca5f501c-6520-4d09-aae2-4f5db74d468f7
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSYca5f501c-6520-4d09-aae2-4f5db74d468f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-323-296800103232920 mL in 1 VIAL, GLASS20 mlHistorical
68001-323-316800103233110 VIAL, GLASS in 1 CARTON (68001-323-31) > 20 mL in 1 VIAL, GLASS (68001-323-29) 2017-04-300000-00-00NoNoCurrent