FDA.reportPublic FDA data

Ertapenem

Product NDC
72266-159
11-digit product format
722660159
Labeler code
72266
Product ID
72266-159_181c0b9d-794e-3e8a-e063-6394a90a7f16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ertapenem Sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fosun Pharma USA Inc
Application
ANDA212040
Marketing category
ANDA
Marketing start
2021-11-01
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
72266-159-01Ertapenem1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,16
72266-159-05Ertapenem5 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,56
72266-159-10Ertapenem10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-159-01EA - Each72266-15956d38913-3987-4f31-9e38-ca32d6cc651d12021-12-08
72266-159-05EA - Each72266-15914a74afe-f48b-45e4-873b-d8c8e18a2be312023-04-07
72266-159-10EA - Each72266-159cc203ca5-cab5-4a54-a433-65e8797d1c4012021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-159ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FOSUN PHARMA USA INC]6Current NDC, Legacy NDC, 3 package rows20240511_c398450c-2b72-86a4-e053-2995a90ad1f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734683ertapenem sodium 1 GM InjectionPSNc398450c-2b72-86a4-e053-2995a90ad1f06
1734683ertapenem 1000 MG InjectionSCDc398450c-2b72-86a4-e053-2995a90ad1f06
1734683ertapenem (as ertapenem sodium 1.046 GM) InjectionSYc398450c-2b72-86a4-e053-2995a90ad1f06
1734683ertapenem 1 GM InjectionSYc398450c-2b72-86a4-e053-2995a90ad1f06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72266-159-01722660159011 in 1 VIAL, SINGLE-DOSEHistorical
72266-159-05722660159055 VIAL, SINGLE-DOSE in 1 CARTON (72266-159-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72266-159-01) 2022-12-090000-00-00NoNoCurrent
72266-159-107226601591010 VIAL, SINGLE-DOSE in 1 CARTON (72266-159-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72266-159-01) 2021-11-010000-00-00NoNoCurrent