FDA.reportPublic FDA data

Meropenem and Sodium Chloride

Product NDC
0264-3183
11-digit product format
002643183
Labeler code
0264
Product ID
0264-3183_19ddbcf7-2edf-449b-b49c-b96ddb82d6c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meropenem and Sodium Chloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA202106
Marketing category
NDA
Marketing start
2015-04-30
Substance
MEROPENEM
Active strength
500 mg/50mL
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 and Sodium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEROPENEM500 mg/50mL

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
0264-3183-11Meropenem and Sodium Chloride50 mL in 1 CONTAINERINJECTION, SOLUTION5025
0264-3183-11Meropenem and Sodium Chloride24 in 1 CASEINJECTION, SOLUTION2425

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-3183-11EA - Each0264-318385cada2d-552b-4099-b411-0127f0e813ed12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEROPENEMACTIVE INGREDIENTFV9J3JU8B1MEROPENEM AND SODIUM CHLORIDE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]9
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XMEROPENEM AND SODIUM CHLORIDE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]9
MEROPENEM ANHYDROUSACTIVE MOIETYYOP6PX0BAOMEROPENEM AND SODIUM CHLORIDE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]9
SODIUM CATIONACTIVE MOIETYLYR4M0NH37MEROPENEM AND SODIUM CHLORIDE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]9
WATERINACTIVE INGREDIENT059QF0KO0RMEROPENEM AND SODIUM CHLORIDE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-3183MEROPENEM AND SODIUM CHLORIDE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]24Current NDC, Legacy NDC, 2 package rows20250104_3b952a55-6ef7-45c8-be21-16eefe37ec2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722939meropenem 1 GM InjectionPSN3b952a55-6ef7-45c8-be21-16eefe37ec2e25
1722934meropenem 500 MG InjectionPSN3b952a55-6ef7-45c8-be21-16eefe37ec2e25
1722939meropenem 1000 MG InjectionSCD3b952a55-6ef7-45c8-be21-16eefe37ec2e25
1722934meropenem 500 MG InjectionSCD3b952a55-6ef7-45c8-be21-16eefe37ec2e25
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSY3b952a55-6ef7-45c8-be21-16eefe37ec2e25
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSY3b952a55-6ef7-45c8-be21-16eefe37ec2e25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-3183-110026431831124 CONTAINER in 1 CASE (0264-3183-11) / 50 mL in 1 CONTAINER24 container2015-04-300000-00-00NoNoCurrent