FDA.reportPublic FDA data

Ertapenem

Product NDC
68001-408
11-digit product format
680010408
Labeler code
68001
Product ID
68001-408_12e7c27b-9d21-bf94-e063-6294a90aedcf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ertapenem Sodium
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA207647
Marketing category
ANDA
Marketing start
2019-08-29
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
68001-408-29Ertapenem20 mL in 1 VIALINJECTION205
68001-408-31Ertapenem10 in 1 CARTONINJECTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-408-29EA - Each68001-408ad3d751e-41df-4559-9511-a0b5d5d8f3a812019-09-05
68001-408-31EA - Each68001-408eefff8e9-9ac7-4a5b-8977-f10e1727ef5612019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-408ERTAPENEM (ERTAPENEM SODIUM) INJECTION [BLUEPOINT LABORATORIES]5Current NDC, Legacy NDC, 2 package rows20240306_8eccc96f-4b59-49ee-9997-365a24f59a24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734683ertapenem sodium 1 GM InjectionPSN8eccc96f-4b59-49ee-9997-365a24f59a245
1734683ertapenem 1000 MG InjectionSCD8eccc96f-4b59-49ee-9997-365a24f59a245
1734683ertapenem (as ertapenem sodium 1.046 GM) InjectionSY8eccc96f-4b59-49ee-9997-365a24f59a245
1734683ertapenem 1 GM InjectionSY8eccc96f-4b59-49ee-9997-365a24f59a245

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-408-296800104082920 mL in 1 VIAL20 mlHistorical
68001-408-316800104083110 VIAL in 1 CARTON (68001-408-31) / 20 mL in 1 VIAL (68001-408-29) 10 vial2019-08-290000-00-00NoNoCurrent