FDA.reportPublic FDA data

MEROPENEM

Product NDC
0781-3000
11-digit product format
007813000
Labeler code
0781
Product ID
0781-3000_43866db8-b8f2-8140-e063-6394a90a90db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MEROPENEM
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA206086
Marketing category
ANDA
Marketing start
2016-08-29
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
0781-3000-94MEROPENEM20 mL in 1 VIALINJECTION2017
0781-3000-95MEROPENEM10 in 1 CARTONINJECTION1017
0781-3000-96MEROPENEM25 in 1 CARTONINJECTION2517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3000-94EA - Each0781-300069a83ff1-ea76-4eb4-ac36-e4b2cedc854612016-10-06
0781-3000-95EA - Each0781-3000952dadaa-c774-4fc4-b294-e7fb7ef51a9f12016-10-06
0781-3000-96EA - Each0781-3000dcb8ecdb-a0f1-42c2-853b-c064b63b618d12016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3000MEROPENEM INJECTION [SANDOZ INC]14Current NDC, Legacy NDC, 3 package rows20250508_0d37e43b-ff8d-495d-b9af-4fd5fce53d56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722939meropenem 1 GM InjectionPSN0d37e43b-ff8d-495d-b9af-4fd5fce53d5617
1722934meropenem 500 MG InjectionPSN0d37e43b-ff8d-495d-b9af-4fd5fce53d5617
1722939meropenem 1000 MG InjectionSCD0d37e43b-ff8d-495d-b9af-4fd5fce53d5617
1722934meropenem 500 MG InjectionSCD0d37e43b-ff8d-495d-b9af-4fd5fce53d5617
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSY0d37e43b-ff8d-495d-b9af-4fd5fce53d5617
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSY0d37e43b-ff8d-495d-b9af-4fd5fce53d5617

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3000-940078130009420 mL in 1 VIAL20 mlHistorical
0781-3000-950078130009510 VIAL in 1 CARTON (0781-3000-95) / 20 mL in 1 VIAL (0781-3000-94) 10 vial2016-08-290000-00-00NoNoCurrent
0781-3000-960078130009625 VIAL in 1 CARTON (0781-3000-96) / 20 mL in 1 VIAL (0781-3000-94) 25 vial2016-08-290000-00-00NoNoCurrent