Ampicillin and Sulbactam

Product NDC
70594-081
11-digit product format
705940081
Labeler code
70594
Product ID
70594-081_4ca436da-1f5a-49da-ae27-50409f8357de
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
ANDA090579
Marketing category
ANDA
Marketing start
2021-01-10
Marketing end
0000-00-00
Substance
AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength
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
2023-12-31
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
70594-081-01EA - Each70594-081fa63f778-cdd1-4bff-95ab-1aa4cb2493bc12021-11-09
70594-081-02EA - Each70594-081b91134d5-bf89-44aa-82da-b98cef6e7b8612021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-081AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]4Legacy NDC20241212_7161f386-6373-4db5-8dfd-d7ddf38ec2f1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70594-081-027059400810210 VIAL in 1 CARTON (70594-081-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01) 10 vial2021-01-100000-00-00NoNoCurrent