FDA.reportPublic FDA data

ampicillin and sulbactam

Product NDC
25021-142
11-digit product format
250210142
Labeler code
25021
Product ID
25021-142_6ea0f274-201c-4a5a-947e-6a94bbfcda30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ampicillin and sulbactam
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA065406
Marketing category
ANDA
Marketing start
2010-06-30
Substance
AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength
1; .5 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 SODIUM1 g/1
SULBACTAM SODIUM.5 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJFN36L5S8K, DKQ4T82YE6
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
25021-142-20ampicillin and sulbactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1016
25021-142-20ampicillin and sulbactam1 in 1 VIALINJECTION, POWDER, FOR SOLUTION116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-142-20EA - Each25021-1421192d05e-e651-4a94-bf0a-0bc2c395765612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ampicillin sodiumACTIVE INGREDIENTJFN36L5S8KAMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]5
sulbactam sodiumACTIVE INGREDIENTDKQ4T82YE6AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]5
ampicillinACTIVE MOIETY7C782967RDAMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]5
sulbactamACTIVE MOIETYS4TF6I2330AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-142AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]16Current NDC, Legacy NDC, 2 package rows20250406_a67ae347-487d-4751-a841-b321e81db26f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659592ampicillin / sulbactam 1.5 GM InjectionPSNa67ae347-487d-4751-a841-b321e81db26f16
1659598ampicillin / sulbactam 3 GM InjectionPSNa67ae347-487d-4751-a841-b321e81db26f16
1659592ampicillin 1000 MG / sulbactam 500 MG InjectionSCDa67ae347-487d-4751-a841-b321e81db26f16
1659598ampicillin 2000 MG / sulbactam 1000 MG InjectionSCDa67ae347-487d-4751-a841-b321e81db26f16
1659592ampicillin (as ampicillin sodium) 1 GM / sulbactam (as sulbactam sodium) 0.5 GM InjectionSYa67ae347-487d-4751-a841-b321e81db26f16
1659598ampicillin (as ampicillin sodium) 2 GM / sulbactam (as sulbactam sodium) 1 GM InjectionSYa67ae347-487d-4751-a841-b321e81db26f16
1659592ampicillin 1 GM / sulbactam 0.5 GM InjectionSYa67ae347-487d-4751-a841-b321e81db26f16
1659598ampicillin 2 GM / sulbactam 1 GM InjectionSYa67ae347-487d-4751-a841-b321e81db26f16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-142-202502101422010 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL10 vial2010-06-300000-00-00NoNoCurrent