FDA.reportPublic FDA data

Meropenem

Product NDC
70121-1454
11-digit product format
701211454
Labeler code
70121
Product ID
70121-1454_c346bc7b-a9e5-4669-bbf0-ea71912fd0fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meropenem
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA205883
Marketing category
ANDA
Marketing start
2016-05-09
Substance
MEROPENEM
Active strength
500 mg/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
Meropenem
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEROPENEM500 mg/20mL

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
70121-1454-1Meropenem20 mL in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION2021
70121-1454-7Meropenem10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1454-1EA - Each70121-1454e6f846cc-aea6-4902-b48e-7c8e9348558112016-10-06
70121-1454-7EA - Each70121-1454f4e10505-43ad-4ba4-bfdb-8dd17f36370f12016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1454MEROPENEM INJECTION, POWDER, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC]20Current NDC, Legacy NDC, 2 package rows20250108_a456013b-b20e-4b29-b2f9-06f18f1ea6bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722939meropenem 1 GM InjectionPSNa456013b-b20e-4b29-b2f9-06f18f1ea6bd21
1722934meropenem 500 MG InjectionPSNa456013b-b20e-4b29-b2f9-06f18f1ea6bd21
1722939meropenem 1000 MG InjectionSCDa456013b-b20e-4b29-b2f9-06f18f1ea6bd21
1722934meropenem 500 MG InjectionSCDa456013b-b20e-4b29-b2f9-06f18f1ea6bd21
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSYa456013b-b20e-4b29-b2f9-06f18f1ea6bd21
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSYa456013b-b20e-4b29-b2f9-06f18f1ea6bd21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1454-17012114540120 mL in 1 VIAL, GLASS20 mlHistorical
70121-1454-77012114540710 VIAL, GLASS in 1 CARTON (70121-1454-7) / 20 mL in 1 VIAL, GLASS (70121-1454-1) 2016-05-090000-00-00NoNoCurrent