FDA.reportPublic FDA data

Ampicillin and Sulbactam

Product NDC
55150-117
11-digit product format
551500117
Labeler code
55150
Product ID
55150-117_13813cd5-ff90-48a1-97d4-3a0f1db1fb45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin Sodium and Sulbactam Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA090349
Marketing category
ANDA
Marketing start
2012-02-10
Substance
AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength
2; 1 g/1; g/1
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 SODIUM2 g/1
SULBACTAM SODIUM1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDKQ4T82YE6, JFN36L5S8K
Rxcui1659592, 1659598

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
55150-117-20Ampicillin and Sulbactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1011
55150-117-20Ampicillin and Sulbactam1 in 1 VIALINJECTION, POWDER, FOR SOLUTION111
55150-117-10Ampicillin and Sulbactam1 in 1 VIALINJECTION, POWDER, FOR SOLUTION13
55150-117-10Ampicillin and Sulbactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-117-10EA - Each55150-1171530c732-dab3-476c-a4de-d2bbf3d4dc8712023-05-05
55150-117-20EA - Each55150-117b2e27cf8-46b8-4926-b85c-720e1b9e2a6212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMPICILLIN SODIUMACTIVE INGREDIENTJFN36L5S8KAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [AUROMEDICS PHARMA LLC]4
SULBACTAM SODIUMACTIVE INGREDIENTDKQ4T82YE6AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [AUROMEDICS PHARMA LLC]4
AMPICILLINACTIVE MOIETY7C782967RDAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [AUROMEDICS PHARMA LLC]4
SULBACTAMACTIVE MOIETYS4TF6I2330AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [AUROMEDICS PHARMA LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-117AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [EUGIA US LLC]10Current NDC, Legacy NDC, 2 package rows20240612_adc92303-b62b-41c8-becf-9c3a4e8c3a6b.zip
55150-117AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [EUGIA US LLC]2Current NDC, Legacy NDC, 2 package rows20241105_16fdfdb9-9e26-48d0-8838-570d30c8e897.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659592ampicillin / sulbactam 1.5 GM InjectionPSNadc92303-b62b-41c8-becf-9c3a4e8c3a6b11
1659598ampicillin / sulbactam 3 GM InjectionPSNadc92303-b62b-41c8-becf-9c3a4e8c3a6b11
1659592ampicillin 1000 MG / sulbactam 500 MG InjectionSCDadc92303-b62b-41c8-becf-9c3a4e8c3a6b11
1659598ampicillin 2000 MG / sulbactam 1000 MG InjectionSCDadc92303-b62b-41c8-becf-9c3a4e8c3a6b11
1659592ampicillin (as ampicillin sodium) 1 GM / sulbactam (as sulbactam sodium) 0.5 GM InjectionSYadc92303-b62b-41c8-becf-9c3a4e8c3a6b11
1659598ampicillin (as ampicillin sodium) 2 GM / sulbactam (as sulbactam sodium) 1 GM InjectionSYadc92303-b62b-41c8-becf-9c3a4e8c3a6b11
1659592ampicillin 1 GM / sulbactam 0.5 GM InjectionSYadc92303-b62b-41c8-becf-9c3a4e8c3a6b11
1659598ampicillin 2 GM / sulbactam 1 GM InjectionSYadc92303-b62b-41c8-becf-9c3a4e8c3a6b11
1659592ampicillin / sulbactam 1.5 GM InjectionPSN16fdfdb9-9e26-48d0-8838-570d30c8e8973
1659598ampicillin / sulbactam 3 GM InjectionPSN16fdfdb9-9e26-48d0-8838-570d30c8e8973
1659592ampicillin 1000 MG / sulbactam 500 MG InjectionSCD16fdfdb9-9e26-48d0-8838-570d30c8e8973
1659598ampicillin 2000 MG / sulbactam 1000 MG InjectionSCD16fdfdb9-9e26-48d0-8838-570d30c8e8973
1659592ampicillin (as ampicillin sodium) 1 GM / sulbactam (as sulbactam sodium) 0.5 GM InjectionSY16fdfdb9-9e26-48d0-8838-570d30c8e8973
1659598ampicillin (as ampicillin sodium) 2 GM / sulbactam (as sulbactam sodium) 1 GM InjectionSY16fdfdb9-9e26-48d0-8838-570d30c8e8973
1659592ampicillin 1 GM / sulbactam 0.5 GM InjectionSY16fdfdb9-9e26-48d0-8838-570d30c8e8973
1659598ampicillin 2 GM / sulbactam 1 GM InjectionSY16fdfdb9-9e26-48d0-8838-570d30c8e8973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-117-105515001171010 VIAL in 1 CARTON (55150-117-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL10 vial2012-02-10NoNoCurrent
55150-117-205515001172010 VIAL in 1 CARTON (55150-117-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL10 vial2012-02-100000-00-00NoNoCurrent