Ertapenem

Product NDC
60505-6196
11-digit product format
605056196
Labeler code
60505
Product ID
60505-6196_0c5d06ec-0530-f60c-e063-6394a90a79b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ertapenem Sodium
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Apotex Corp
Application
ANDA207647
Marketing category
ANDA
Marketing start
2019-04-02
Substance
ERTAPENEM SODIUM
Active strength
1 g/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
Ertapenem
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERTAPENEM SODIUM1 g/20mL

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
60505-6196-0Ertapenem20 mL in 1 VIALINJECTION206
60505-6196-4Ertapenem10 in 1 CARTONINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6196-0EA - Each60505-6196aca5aeac-84a2-4cb5-8623-40ac0d96973212019-05-02
60505-6196-4EA - Each60505-619635c9ed70-d2f6-42af-b4fd-dced2b72466b12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6196ERTAPENEM (ERTAPENEM SODIUM) INJECTION [APOTEX CORP]6Current NDC, Legacy NDC, 2 package rows20231213_468105b9-48b3-4477-82c7-e7fb92460e28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734683ertapenem sodium 1 GM InjectionPSN468105b9-48b3-4477-82c7-e7fb92460e286
1734683ertapenem 1000 MG InjectionSCD468105b9-48b3-4477-82c7-e7fb92460e286
1734683ertapenem (as ertapenem sodium 1.046 GM) InjectionSY468105b9-48b3-4477-82c7-e7fb92460e286
1734683ertapenem 1 GM InjectionSY468105b9-48b3-4477-82c7-e7fb92460e286

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-6196-06050561960020 mL in 1 VIAL20 mlHistorical
60505-6196-46050561960410 VIAL in 1 CARTON (60505-6196-4) / 20 mL in 1 VIAL (60505-6196-0) 10 vial2019-04-020000-00-00NoNoCurrent