Ampicillin and Sulbactam

Product NDC
55150-118
11-digit product format
551500118
Labeler code
55150
Product ID
55150-118_4681869d-6a9c-4aaf-90e2-090469e45012
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin Sodium and Sulbactam Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA090339
Marketing category
ANDA
Marketing start
2012-02-10
Substance
AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength
100; 50 mg/mL; mg/mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ampicillin and Sulbactam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPICILLIN SODIUM100 mg/mL
SULBACTAM SODIUM50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJFN36L5S8K, DKQ4T82YE6
Rxcui240984

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
55150-118-99Ampicillin and Sulbactam1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION114
55150-118-99Ampicillin and Sulbactam100 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION10014
55150-118-01Ampicillin and Sulbactam1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION13
55150-118-01Ampicillin and Sulbactam100 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-118-01EA - Each55150-1184075605c-cb29-4b46-9bff-9e5d7d06677312023-05-05
55150-118-99EA - Each55150-118321f9543-8913-4d94-a9e2-dfcf83f0cbcd12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-118AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [EUGIA US LLC]13Current NDC, Legacy NDC, 2 package rows20240608_2709e9fc-2341-4382-af72-c2e3201bd77a.zip
55150-118AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [EUGIA US LLC]1Current NDC, Legacy NDC, 2 package rows20230414_437a26f4-776b-4f74-99b2-09ad79831b0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240984ampicillin 100 MG / sulbactam 50 MG in ML Injectable SolutionPSN2709e9fc-2341-4382-af72-c2e3201bd77a14
240984ampicillin 100 MG/ML / sulbactam 50 MG/ML Injectable SolutionSCD2709e9fc-2341-4382-af72-c2e3201bd77a14
240984ampicillin (as ampicillin sodium) 10 GM / sulbactam (as sulbactam sodium) 5 GM per 100 ML Injectable SolutionSY2709e9fc-2341-4382-af72-c2e3201bd77a14
240984ampicillin (as ampicillin sodium) 100 MG/ML / sulbactam (as sulbactam sodium) 50 MG/ML Injectable SolutionSY2709e9fc-2341-4382-af72-c2e3201bd77a14
240984ampicillin 100 MG / sulbactam 50 MG in ML Injectable SolutionPSN437a26f4-776b-4f74-99b2-09ad79831b0c3
240984ampicillin 100 MG/ML / sulbactam 50 MG/ML Injectable SolutionSCD437a26f4-776b-4f74-99b2-09ad79831b0c3
240984ampicillin (as ampicillin sodium) 10 GM / sulbactam (as sulbactam sodium) 5 GM per 100 ML Injectable SolutionSY437a26f4-776b-4f74-99b2-09ad79831b0c3
240984ampicillin (as ampicillin sodium) 100 MG/ML / sulbactam (as sulbactam sodium) 50 MG/ML Injectable SolutionSY437a26f4-776b-4f74-99b2-09ad79831b0c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-118-01551500118011 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE2012-02-10NoNoCurrent
55150-118-99551500118991 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE2012-02-100000-00-00NoNoCurrent