FDA.reportPublic FDA data

UNASYN

Product NDC
0049-0013
11-digit product format
000490013
Labeler code
0049
Product ID
0049-0013_6b0299f2-a683-4c8f-bf62-b79d5f652b41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ampicillin sodium and sulbactam sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Roerig
Application
NDA050608
Marketing category
NDA
Marketing start
1991-11-22
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
UNASYN
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
UniiDKQ4T82YE6, JFN36L5S8K
Rxcui1659592, 1659595, 1659598, 1659600

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
0049-0013-81UNASYN1 in 1 VIALINJECTION, POWDER, FOR SOLUTION145
0049-0013-83UNASYN10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1045

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-0013-81EA - Each0049-00134a5760d0-102a-4819-905a-e251cc0e839412015-05-05
0049-0013-83EA - Each0049-0013143b0e6b-3431-4252-872e-58f1df14dc2612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMPICILLIN SODIUMACTIVE INGREDIENTJFN36L5S8KUNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG]13
SULBACTAM SODIUMACTIVE INGREDIENTDKQ4T82YE6UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG]13
AMPICILLINACTIVE MOIETY7C782967RDUNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG]13
SULBACTAMACTIVE MOIETYS4TF6I2330UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0049-0013UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG]45Current NDC, Legacy NDC, 2 package rows20250515_155c7ec0-5862-404f-b1d0-f278f8a8bbda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659592ampicillin / sulbactam 1.5 GM InjectionPSN155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659598ampicillin / sulbactam 3 GM InjectionPSN155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659595Unasyn 1.5 GM InjectionPSN155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659600Unasyn 3 GM InjectionPSN155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659595ampicillin 1000 MG / sulbactam 500 MG Injection [Unasyn]SBD155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659600ampicillin 2000 MG / sulbactam 1000 MG Injection [Unasyn]SBD155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659592ampicillin 1000 MG / sulbactam 500 MG InjectionSCD155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659598ampicillin 2000 MG / sulbactam 1000 MG InjectionSCD155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659592ampicillin (as ampicillin sodium) 1 GM / sulbactam (as sulbactam sodium) 0.5 GM InjectionSY155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659598ampicillin (as ampicillin sodium) 2 GM / sulbactam (as sulbactam sodium) 1 GM InjectionSY155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659592ampicillin 1 GM / sulbactam 0.5 GM InjectionSY155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659598ampicillin 2 GM / sulbactam 1 GM InjectionSY155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659595Unasyn (ampicillin / sulbactam) 1.5 GM InjectionSY155c7ec0-5862-404f-b1d0-f278f8a8bbda45
1659600Unasyn (ampicillin / sulbactam) 3 GM InjectionSY155c7ec0-5862-404f-b1d0-f278f8a8bbda45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0049-0013-81000490013811 in 1 VIALHistorical
0049-0013-830004900138310 VIAL in 1 CARTON (0049-0013-83) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0013-81) 10 vial1991-11-220000-00-00NoNoCurrent