FDA.reportPublic FDA data

ampicillin sodium and sulbactam sodium

Product NDC
72572-136
11-digit product format
725720136
Labeler code
72572
Product ID
72572-136_3e4c5fd9-5f8b-0b79-e063-6294a90a2885
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ampicillin sodium and sulbactam sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA201024
Marketing category
ANDA
Marketing start
2025-09-08
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 sodium and sulbactam sodium
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
UniiJFN36L5S8K, DKQ4T82YE6
Rxcui1659598

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
72572-136-10ampicillin sodium and sulbactam sodium1 in 1 VIALINJECTION, POWDER, FOR SOLUTION11
72572-136-10ampicillin sodium and sulbactam sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-136-10EA - Each72572-1360ae5240b-53fd-40b0-b8a2-090aeae3a1d012025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659598ampicillin / sulbactam 3 GM InjectionPSNe98a36a1-b75b-42b9-ad1a-05004e9587b61
1659598ampicillin 2000 MG / sulbactam 1000 MG InjectionSCDe98a36a1-b75b-42b9-ad1a-05004e9587b61
1659598ampicillin (as ampicillin sodium) 2 GM / sulbactam (as sulbactam sodium) 1 GM InjectionSYe98a36a1-b75b-42b9-ad1a-05004e9587b61
1659598ampicillin 2 GM / sulbactam 1 GM InjectionSYe98a36a1-b75b-42b9-ad1a-05004e9587b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72572-136-107257201361010 VIAL in 1 CARTON (72572-136-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL10 vial2025-09-08NoNoHistorical