Ampicillin Sodium and Sulbactam Sodium

Product NDC
83270-308
11-digit product format
832700308
Labeler code
83270
Product ID
83270-308_44a1dfcc-d7d6-08ec-e063-6294a90a8ca5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ampicillin sodium, sulbactam sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
ONESOURCE SPECIALTY PHARMA LIMITED
Application
ANDA202197
Marketing category
ANDA
Marketing start
2025-05-01
Substance
AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength
10; 5 g/15g; g/15g
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 Sodium and Sulbactam Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPICILLIN SODIUM10 g/15g
SULBACTAM SODIUM5 g/15g

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
83270-308-01Ampicillin Sodium and Sulbactam Sodium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11
83270-308-01Ampicillin Sodium and Sulbactam Sodium15 g in 1 BOTTLEINJECTION, POWDER, FOR SOLUTION151

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240984ampicillin 100 MG / sulbactam 50 MG in ML Injectable SolutionPSN573aca0c-111e-4ed3-9bcd-18136cae12cc1
240984ampicillin 100 MG/ML / sulbactam 50 MG/ML Injectable SolutionSCD573aca0c-111e-4ed3-9bcd-18136cae12cc1
240984ampicillin (as ampicillin sodium) 10 GM / sulbactam (as sulbactam sodium) 5 GM per 100 ML Injectable SolutionSY573aca0c-111e-4ed3-9bcd-18136cae12cc1
240984ampicillin (as ampicillin sodium) 100 MG/ML / sulbactam (as sulbactam sodium) 50 MG/ML Injectable SolutionSY573aca0c-111e-4ed3-9bcd-18136cae12cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83270-308-01832700308011 BOTTLE in 1 CARTON (83270-308-01) / 15 g in 1 BOTTLE1 bottle2025-05-01NoNoCurrent