FDA.reportPublic FDA data

Ertapenem

Product NDC
25021-199
11-digit product format
250210199
Labeler code
25021
Product ID
25021-199_0a3ba6c5-088b-4c94-8ece-b76034ecccb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ertapenem Sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA218067
Marketing category
ANDA
Marketing start
2025-08-15
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
25021-199-20Ertapenem10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101
25021-199-20Ertapenem1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,11
25021-199-66Ertapenem10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101
25021-199-66Ertapenem1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-199-20EA - Each25021-19954ecae08-ae31-459d-9a04-ab433d7addaf12025-09-12
25021-199-66EA - Each25021-19966dee059-cc30-4b8b-bd59-36eb90bec6a312026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734683ertapenem sodium 1 GM InjectionPSN124775ed-1271-4581-be52-b7a08c91283d1
1734683ertapenem sodium 1 GM InjectionPSN39bd4d41-36f8-4826-a733-a5ad1a531c021
1734683ertapenem 1000 MG InjectionSCD124775ed-1271-4581-be52-b7a08c91283d1
1734683ertapenem 1000 MG InjectionSCD39bd4d41-36f8-4826-a733-a5ad1a531c021
1734683ertapenem (as ertapenem sodium 1.046 GM) InjectionSY124775ed-1271-4581-be52-b7a08c91283d1
1734683ertapenem (as ertapenem sodium 1.046 GM) InjectionSY39bd4d41-36f8-4826-a733-a5ad1a531c021
1734683ertapenem 1 GM InjectionSY124775ed-1271-4581-be52-b7a08c91283d1
1734683ertapenem 1 GM InjectionSY39bd4d41-36f8-4826-a733-a5ad1a531c021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-199-202502101992010 VIAL in 1 CARTON (25021-199-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL10 vial2025-08-15NoNoHistorical
25021-199-662502101996610 VIAL in 1 CARTON (25021-199-66) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL10 vial2026-01-15NoNoHistorical