Ampicillin and Sulbactam

Product NDC
0641-6122
11-digit product format
006416122
Labeler code
0641
Product ID
0641-6122_6ababc9a-b6ac-4fe9-8d69-d94eab27ac24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin and Sulbactam
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065406
Marketing category
ANDA
Marketing start
2009-12-22
Marketing end
0000-00-00
Substance
AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength
250 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0641-6122-102025-03-12C16284748780-12cef2736-750d-d83d-e063-dadaa90ab31f942ea2a7-8a1b-405e-a802-2ff0debc388b
0641-6122-102025-01-30C16284748780-12cef2736-750d-d83d-e063-dadaa90ab31f942ea2a7-8a1b-405e-a802-2ff0debc388b

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6122-100064161221010 VIAL in 1 CARTON (0641-6122-10) > 4 mL in 1 VIAL (0641-6122-01) 10 vial2009-12-220000-00-00NoNoCurrent