Ampicillin and Sulbactam

Product NDC
70594-083
11-digit product format
705940083
Labeler code
70594
Product ID
70594-083_7f6b70bd-3b9c-4e28-bd56-98d84bdd2acb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMPICILLIN SODIUM and SULBACTAM SODIUM
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Xellia Pharmaceuticals USA LLC
Application
ANDA090578
Marketing category
ANDA
Marketing start
2021-01-10
Marketing end
0000-00-00
Substance
AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength
100 mg/mL; mg/mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-083-01EA - Each70594-0839b4c2aad-fc10-4eac-9e79-2070fc7bf77f12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-083AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]4Legacy NDC20241213_2bfc6187-c9fc-4115-92d6-53910b5960da.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70594-083-01705940083011 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-083-01) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE2021-01-100000-00-00NoNoCurrent