Ampicillin and Sulbactam

Product NDC
36000-095
11-digit product format
360000095
Labeler code
36000
Product ID
36000-095_96960f4b-4cca-496a-9b09-60b9cbb72d69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin sodium and sulbactam sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Claris Life Sciences Inc.
Application
ANDA201406
Marketing category
ANDA
Marketing start
2015-12-14
Marketing end
0000-00-00
Substance
AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength
2 g/1; g/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36000-095-102020-01-31C16284748780-19d75b9d1-03b7-f424-e053-dadaa90a57ceAmpicillin and Sulbactam for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36000-095-10Ampicillin and Sulbactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION103
36000-095-10Ampicillin and Sulbactam1 in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36000-095AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [CLARIS LIFE SCIENCES INC.]3Legacy NDC, 2 package rows20151215_bb78b01f-b235-4a3e-b3d2-24543d3fd56c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659592ampicillin / sulbactam 1.5 GM InjectionPSNbb78b01f-b235-4a3e-b3d2-24543d3fd56c3
1659598ampicillin / sulbactam 3 GM InjectionPSNbb78b01f-b235-4a3e-b3d2-24543d3fd56c3
1659592ampicillin 1000 MG / sulbactam 500 MG InjectionSCDbb78b01f-b235-4a3e-b3d2-24543d3fd56c3
1659598ampicillin 2000 MG / sulbactam 1000 MG InjectionSCDbb78b01f-b235-4a3e-b3d2-24543d3fd56c3
1659592ampicillin (as ampicillin sodium) 1 GM / sulbactam (as sulbactam sodium) 0.5 GM InjectionSYbb78b01f-b235-4a3e-b3d2-24543d3fd56c3
1659598ampicillin (as ampicillin sodium) 2 GM / sulbactam (as sulbactam sodium) 1 GM InjectionSYbb78b01f-b235-4a3e-b3d2-24543d3fd56c3
1659592ampicillin 1 GM / sulbactam 0.5 GM InjectionSYbb78b01f-b235-4a3e-b3d2-24543d3fd56c3
1659598ampicillin 2 GM / sulbactam 1 GM InjectionSYbb78b01f-b235-4a3e-b3d2-24543d3fd56c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
36000-095-103600000951010 in 1 CARTONHistorical