Amoxicillin and Clavulanate Potassium

Product NDC
50090-3047
11-digit product format
500903047
Labeler code
50090
Product ID
50090-3047_15c6c197-ebaa-402a-b718-a0014072505e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065089
Marketing category
ANDA
Marketing start
2005-01-13
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
400 mg/5mL; mg/5mL
Pharmacologic classes
beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3047-02023-02-07C16284748780-1f386c649-ad14-0266-e053-dadaa90a7c1a50ba4a49-731f-4d90-8f8f-c7d1208afbea
50090-3047-02023-01-30C16284748780-1f386c649-ad14-0266-e053-dadaa90a7c1a50ba4a49-731f-4d90-8f8f-c7d1208afbea

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3047-0ML - Milliliter50090-3047a5fc661b-8297-49b2-977f-84189615a34212019-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3047-050090304700100 mL in 1 BOTTLE (50090-3047-0) 100 ml2017-06-120000-00-00NoNoCurrent