Amoxicillin and Clavulanate Potassium

Product NDC
50090-0831
11-digit product format
500900831
Labeler code
50090
Product ID
50090-0831_61359ca5-ce2e-43c5-a650-fe2816c5c5e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065191
Marketing category
ANDA
Marketing start
2007-12-01
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANIC ACID
Active strength
400 mg/5mL; mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0831-02023-02-06C16284748780-1f386c649-c5bf-0266-e053-dadaa90a7c1a87c9a8ba-85a3-4efd-9c3d-9a887fb9369b
50090-0831-02023-01-30C16284748780-1f386c649-c5bf-0266-e053-dadaa90a7c1a87c9a8ba-85a3-4efd-9c3d-9a887fb9369b

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0831-0ML - Milliliter50090-083123b82234-5509-47c4-98dc-7ce353a79c4312018-10-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0831-050090083100100 mL in 1 BOTTLE (50090-0831-0) 100 ml2014-11-280000-00-00NoNoCurrent