FDA.reportPublic FDA data

Ampicillin Sodium and Sulbactam Sodium

Product NDC
72485-416
11-digit product format
724850416
Labeler code
72485
Product ID
72485-416_44a1fdb7-5659-23bc-e063-6294a90a1ccd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ampicillin sodium, sulbactam sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA201024
Marketing category
ANDA
Marketing start
2023-07-21
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 Sodium and Sulbactam Sodium
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
72485-416-01Ampicillin Sodium and Sulbactam Sodium1 in 1 VIALINJECTION, POWDER, FOR SOLUTION14
72485-416-10Ampicillin Sodium and Sulbactam Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-416-01EA - Each72485-416b0281f45-b3db-48d1-b42c-0ee31bfa0f4c12024-01-04
72485-416-10EA - Each72485-41608af91d4-1331-48d8-80d4-493047b6388012024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-416AMPICILLIN SODIUM AND SULBACTAM SODIUM (AMPICILLIN SODIUM, SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ARMAS PHARMACEUTICALS INC.]3Current NDC, 2 package rows20241030_ac6f8158-9d7e-4b99-af3c-0407c5287b57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659592ampicillin / sulbactam 1.5 GM InjectionPSNac6f8158-9d7e-4b99-af3c-0407c5287b574
1659598ampicillin / sulbactam 3 GM InjectionPSNac6f8158-9d7e-4b99-af3c-0407c5287b574
1659592ampicillin 1000 MG / sulbactam 500 MG InjectionSCDac6f8158-9d7e-4b99-af3c-0407c5287b574
1659598ampicillin 2000 MG / sulbactam 1000 MG InjectionSCDac6f8158-9d7e-4b99-af3c-0407c5287b574
1659592ampicillin (as ampicillin sodium) 1 GM / sulbactam (as sulbactam sodium) 0.5 GM InjectionSYac6f8158-9d7e-4b99-af3c-0407c5287b574
1659598ampicillin (as ampicillin sodium) 2 GM / sulbactam (as sulbactam sodium) 1 GM InjectionSYac6f8158-9d7e-4b99-af3c-0407c5287b574
1659592ampicillin 1 GM / sulbactam 0.5 GM InjectionSYac6f8158-9d7e-4b99-af3c-0407c5287b574
1659598ampicillin 2 GM / sulbactam 1 GM InjectionSYac6f8158-9d7e-4b99-af3c-0407c5287b574

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72485-416-01724850416011 in 1 VIALHistorical
72485-416-107248504161010 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01) 10 vial2023-07-21NoNoHistorical