FDA.reportPublic FDA data

ERTAPENEM SODIUM

Product NDC
43598-901
11-digit product format
435980901
Labeler code
43598
Product ID
43598-901_39078864-5998-878d-b70d-8f46a61bbf02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ertapenem
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Dr.Reddys Laboratories Inc.,
Application
ANDA212040
Marketing category
ANDA
Marketing start
2021-04-29
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 SODIUM
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
43598-901-11ERTAPENEM SODIUM1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,14
43598-901-58ERTAPENEM SODIUM10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-901-11EA - Each43598-901d1b9e0f8-1a1d-463b-9e6b-5f1f77f67e0312021-05-05
43598-901-58EA - Each43598-90162d1758d-889b-41ca-bba1-f59be9a80b4612021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-901ERTAPENEM SODIUM (ERTAPENEM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR.REDDYS LABORATORIES INC.,]4Current NDC, Legacy NDC, 2 package rows20240627_32d9f095-ca39-7e22-6264-b54f2daaee57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734683ertapenem sodium 1 GM InjectionPSN32d9f095-ca39-7e22-6264-b54f2daaee574
1734683ertapenem 1000 MG InjectionSCD32d9f095-ca39-7e22-6264-b54f2daaee574
1734683ertapenem (as ertapenem sodium 1.046 GM) InjectionSY32d9f095-ca39-7e22-6264-b54f2daaee574
1734683ertapenem 1 GM InjectionSY32d9f095-ca39-7e22-6264-b54f2daaee574

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-901-11435980901111 in 1 VIAL, SINGLE-DOSEHistorical
43598-901-584359809015810 VIAL, SINGLE-DOSE in 1 CARTON (43598-901-58) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (43598-901-11) 2021-04-290000-00-00NoNoCurrent