Amoxicillin and Clavulanate Potassium

Product NDC
50090-3414
11-digit product format
500903414
Labeler code
50090
Product ID
50090-3414_5dafbacb-3d00-4086-b06e-edb52e0d0177
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203824
Marketing category
ANDA
Marketing start
2016-08-23
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
875 mg/1; mg/1
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
50090-3414-02023-02-07C16284748780-1f386c649-f98d-0266-e053-dadaa90a7c1a93c34979-5f48-4092-a71d-539fe99a6c78
50090-3414-02023-01-30C16284748780-1f386c649-f98d-0266-e053-dadaa90a7c1a93c34979-5f48-4092-a71d-539fe99a6c78

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3414-0EA - Each50090-3414b7be013f-c5c7-4d16-9b72-963455891f8712021-09-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3414-05009034140020 TABLET in 1 BOTTLE (50090-3414-0) 20 tablet2018-03-240000-00-00NoNoCurrent