FDA.reportPublic FDA data

Ampicillin and Sulbactam

Product NDC
83634-108
11-digit product format
836340108
Labeler code
83634
Product ID
83634-108_2facc8c4-46fb-4562-a621-a856ec473567
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ampicillin and sulbactam
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Avenacy, LLC
Application
ANDA065314
Marketing category
ANDA
Marketing start
2025-02-01
Substance
AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength
10; 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 SODIUM10 g/1
SULBACTAM SODIUM5 g/1

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
83634-108-99Ampicillin and Sulbactam1 in 1 BOTTLEINJECTION, POWDER, FOR SOLUTION12
83634-108-99Ampicillin and Sulbactam1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83634-108AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [AVENACY INC.]1Current NDC, 2 package rows20250201_577dd6f0-d56a-4c82-9f72-274c3a4a0f01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240984ampicillin 100 MG / sulbactam 50 MG in ML Injectable SolutionPSN577dd6f0-d56a-4c82-9f72-274c3a4a0f012
240984ampicillin 100 MG/ML / sulbactam 50 MG/ML Injectable SolutionSCD577dd6f0-d56a-4c82-9f72-274c3a4a0f012
240984ampicillin (as ampicillin sodium) 10 GM / sulbactam (as sulbactam sodium) 5 GM per 100 ML Injectable SolutionSY577dd6f0-d56a-4c82-9f72-274c3a4a0f012
240984ampicillin (as ampicillin sodium) 100 MG/ML / sulbactam (as sulbactam sodium) 50 MG/ML Injectable SolutionSY577dd6f0-d56a-4c82-9f72-274c3a4a0f012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83634-108-99836340108991 BOTTLE in 1 CARTON (83634-108-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE1 bottle2025-04-24NoNoCurrent