FDA.reportPublic FDA data

MEROPENEM

Product NDC
70594-076
11-digit product format
705940076
Labeler code
70594
Product ID
70594-076_3ee484ef-4e7f-464a-ac2e-7963d9dc5df6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MEROPENEM
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Xellia Pharmaceuticals USA LLC
Application
ANDA206141
Marketing category
ANDA
Marketing start
2021-06-28
Substance
MEROPENEM
Active strength
1 g/1
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/1

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
70594-076-01MEROPENEM1 in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION17
70594-076-02MEROPENEM10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-076-01EA - Each70594-0763a2bd25a-5c22-4ccf-b37f-0926746c120712021-09-07
70594-076-02EA - Each70594-07654f1a282-9f29-40c7-aa18-77ffefeb381612021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-076MEROPENEM INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]7Current NDC, Legacy NDC, 2 package rows20241211_06d84c55-94ff-46e5-8477-b8881c12eb0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722939meropenem 1 GM InjectionPSN06d84c55-94ff-46e5-8477-b8881c12eb0a7
1722934meropenem 500 MG InjectionPSN06d84c55-94ff-46e5-8477-b8881c12eb0a7
1722939meropenem 1000 MG InjectionSCD06d84c55-94ff-46e5-8477-b8881c12eb0a7
1722934meropenem 500 MG InjectionSCD06d84c55-94ff-46e5-8477-b8881c12eb0a7
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSY06d84c55-94ff-46e5-8477-b8881c12eb0a7
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSY06d84c55-94ff-46e5-8477-b8881c12eb0a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70594-076-01705940076011 in 1 VIAL, GLASSHistorical
70594-076-027059400760210 VIAL, GLASS in 1 CARTON (70594-076-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (70594-076-01) 2021-06-280000-00-00NoNoCurrent