ertapenem

Product NDC
44567-820
11-digit product format
445670820
Labeler code
44567
Product ID
44567-820_befbf704-5aae-474b-8457-c77b2ab7835e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ertapenem
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA208790
Marketing category
ANDA
Marketing start
2020-01-07
Substance
ERTAPENEM SODIUM
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
ertapenem
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERTAPENEM SODIUM1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2T90KE67L0
Rxcui1734683

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aa4e6ef0-aff8-b16d-a7b0-a1baf91ab629Product name620250623

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44567-820-01ertapenem1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,17
44567-820-10ertapenem10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-820ERTAPENEM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WG CRITICAL CARE, LLC]7Current NDC, Legacy NDC, 2 package rows20221109_cf3cfa6b-211c-452b-b18b-e462b21e6909.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734683ertapenem sodium 1 GM InjectionPSNcf3cfa6b-211c-452b-b18b-e462b21e69097
1734683ertapenem 1000 MG InjectionSCDcf3cfa6b-211c-452b-b18b-e462b21e69097
1734683ertapenem (as ertapenem sodium 1.046 GM) InjectionSYcf3cfa6b-211c-452b-b18b-e462b21e69097
1734683ertapenem 1 GM InjectionSYcf3cfa6b-211c-452b-b18b-e462b21e69097

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
44567-820-01445670820011 in 1 VIAL, SINGLE-DOSEHistorical
44567-820-104456708201010 VIAL, SINGLE-DOSE in 1 CARTON (44567-820-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (44567-820-01) 2020-01-070000-00-00NoNoCurrent