Meropenem

Product NDC
81962-001
11-digit product format
819620001
Labeler code
81962
Product ID
81962-001_4caa1d3a-1dba-7392-e063-6294a90a0080
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meropenem
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
BROOKS STERISCIENCE LIMITED
Application
ANDA216154
Marketing category
ANDA
Marketing start
2023-05-31
Substance
MEROPENEM
Active strength
1 g/20mL
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/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
81962-001-01Meropenem1 in 1 CARTONINJECTION110
81962-001-01Meropenem20 mL in 1 VIALINJECTION2010
81962-001-02Meropenem20 mL in 1 VIALINJECTION2010
81962-001-02Meropenem10 in 1 CARTONINJECTION1010
81962-001-03Meropenem25 in 1 CARTONINJECTION2510
81962-001-03Meropenem20 mL in 1 VIALINJECTION2010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81962-001MEROPENEM INJECTION [BROOKS STERISCIENCE LIMITED]9Current NDC, Legacy NDC, 6 package rows20250125_58e165b7-e230-4459-abf9-06d5ca1dd7b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722939meropenem 1 GM InjectionPSN58e165b7-e230-4459-abf9-06d5ca1dd7b210
1722934meropenem 500 MG InjectionPSN58e165b7-e230-4459-abf9-06d5ca1dd7b210
1722939meropenem 1000 MG InjectionSCD58e165b7-e230-4459-abf9-06d5ca1dd7b210
1722934meropenem 500 MG InjectionSCD58e165b7-e230-4459-abf9-06d5ca1dd7b210
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSY58e165b7-e230-4459-abf9-06d5ca1dd7b210
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSY58e165b7-e230-4459-abf9-06d5ca1dd7b210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81962-001-01819620001011 VIAL in 1 CARTON (81962-001-01) / 20 mL in 1 VIAL1 vial2023-05-310000-00-00NoNoCurrent
81962-001-028196200010210 VIAL in 1 CARTON (81962-001-02) / 20 mL in 1 VIAL10 vial2023-05-310000-00-00NoNoCurrent
81962-001-038196200010325 VIAL in 1 CARTON (81962-001-03) / 20 mL in 1 VIAL25 vial2023-05-310000-00-00NoNoCurrent