FDA.reportPublic FDA data

Ampicillin and Sulbactam

Product NDC
44567-150
11-digit product format
445670150
Labeler code
44567
Product ID
44567-150_f39082b6-3fda-44dd-a379-1bc57e68733d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin and Sulbactam
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA201406
Marketing category
ANDA
Marketing start
2021-11-30
Substance
AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength
2; 1 g/20mL; g/20mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ampicillin and Sulbactam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPICILLIN SODIUM2 g/20mL
SULBACTAM SODIUM1 g/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJFN36L5S8K, DKQ4T82YE6
Rxcui1659598

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9d6ee0-43ae-43c7-aa52-3d5a936186d6Product name120250722
1f6437d4-fe6e-4912-889c-84576c1da4d8Product name120231019
4fe9b92f-7dcd-4058-8def-e75f4dcd5ab3Product name220160201
c9385d77-2af7-47a4-bc97-1127e71caf9bProduct name320160201
05b6b9ae-4ba4-27ee-4c8c-f72b41de3815Product name520151207
b353113e-7b3d-4b1f-a286-b96a3a5eac85Product name320151026
8c59be9b-72b0-49e8-b7ef-1a80c10599deProduct name320150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44567-150-10Ampicillin and Sulbactam20 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION207
44567-150-10Ampicillin and Sulbactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-150-10EA - Each44567-150317d8eea-7c90-4d51-a768-97a45f3e994512022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-150AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]6Current NDC, Legacy NDC, 2 package rows20250510_72a37674-8cb2-4b40-aac8-d345ffcf22f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659598ampicillin / sulbactam 3 GM InjectionPSN72a37674-8cb2-4b40-aac8-d345ffcf22f27
1659598ampicillin 2000 MG / sulbactam 1000 MG InjectionSCD72a37674-8cb2-4b40-aac8-d345ffcf22f27
1659598ampicillin (as ampicillin sodium) 2 GM / sulbactam (as sulbactam sodium) 1 GM InjectionSY72a37674-8cb2-4b40-aac8-d345ffcf22f27
1659598ampicillin 2 GM / sulbactam 1 GM InjectionSY72a37674-8cb2-4b40-aac8-d345ffcf22f27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-150-104456701501010 VIAL in 1 CARTON (44567-150-10) / 20 mL in 1 VIAL10 vial2021-11-300000-00-00NoNoCurrent