Ampicillin and Sulbactam

Product NDC
0641-6121
11-digit product format
006416121
Labeler code
0641
Product ID
0641-6121_68fc19c6-3431-4c1d-bd50-b685aae800d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin and Sulbactam
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
West-Ward Pharmaceuticals Corp.
Application
ANDA065403
Marketing category
ANDA
Marketing start
2009-12-03
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6121-01EA - Each0641-6121844c66f9-f205-4c02-8436-533aa901efef12013-04-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6121-0100641612101100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6121-01) 100 ml2009-12-030000-00-00NoNoCurrent