FDA.reportPublic FDA data

Ertapenem

Product NDC
0143-9429
11-digit product format
001439429
Labeler code
0143
Product ID
0143-9429_e50b4c3f-e5c3-45c2-b3a6-d0e87d996109
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ertapenem sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA218067
Marketing category
ANDA
Marketing start
2025-02-28
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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9429-01Ertapenem1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,12
0143-9429-10Ertapenem10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9429-01EA - Each0143-9429c674c63f-de39-4040-8354-a13c37e6f96912025-06-13
0143-9429-10EA - Each0143-9429a674799e-0b3b-44e6-8088-931cfe7dca8f12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9429ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]2Current NDC, 2 package rows20250228_b88c0709-33fe-47db-8ae8-8bad6692d5d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734683ertapenem sodium 1 GM InjectionPSNb88c0709-33fe-47db-8ae8-8bad6692d5d52
1734683ertapenem 1000 MG InjectionSCDb88c0709-33fe-47db-8ae8-8bad6692d5d52
1734683ertapenem (as ertapenem sodium 1.046 GM) InjectionSYb88c0709-33fe-47db-8ae8-8bad6692d5d52
1734683ertapenem 1 GM InjectionSYb88c0709-33fe-47db-8ae8-8bad6692d5d52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0143-9429-01001439429011 in 1 VIAL, SINGLE-DOSEHistorical
0143-9429-100014394291010 VIAL, SINGLE-DOSE in 1 CARTON (0143-9429-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9429-01) 2025-02-28NoNoHistorical