Meropenem

Product NDC
25021-161
11-digit product format
250210161
Labeler code
25021
Product ID
25021-161_88e3a173-e663-4d73-bcc8-0096bdc4aff4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meropenem
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA216424
Marketing category
ANDA
Marketing start
2025-11-01
Substance
MEROPENEM
Active strength
1 g/30mL
Pharmacologic classes
Carbapenems [CS], Penem Antibacterial [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Meropenem
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEROPENEM1 g/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFV9J3JU8B1
Rxcui1722934, 1722939

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
437602ae-8b0a-4f4e-8f97-eabd2e27845eProduct name620250305
407c0246-8bda-450d-8667-f622a350d05cProduct name120231023
b1a98f8c-7b20-4bc2-b772-289c5d0949a9Product name120171106
940e5686-419d-4429-a15d-7bf46e26b176Product name120150929

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-161-30Meropenem30 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION302
25021-161-30Meropenem10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722939meropenem 1 GM InjectionPSNe8848f4a-bca9-4978-b0a1-38483fd4d6392
1722934meropenem 500 MG InjectionPSNe8848f4a-bca9-4978-b0a1-38483fd4d6392
1722939meropenem 1000 MG InjectionSCDe8848f4a-bca9-4978-b0a1-38483fd4d6392
1722934meropenem 500 MG InjectionSCDe8848f4a-bca9-4978-b0a1-38483fd4d6392
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSYe8848f4a-bca9-4978-b0a1-38483fd4d6392
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSYe8848f4a-bca9-4978-b0a1-38483fd4d6392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-161-302502101613010 VIAL in 1 CARTON (25021-161-30) / 30 mL in 1 VIAL10 vial2025-11-01NoNoCurrent