Amoxicillin and Clavulanate Potassium

Product NDC
68788-8996
11-digit product format
687888996
Labeler code
68788
Product ID
68788-8996_91d553e5-511b-4933-93b5-5f8406367691
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065098
Marketing category
ANDA
Marketing start
2016-02-11
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
200 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
68788-8996-12021-02-03C16284748780-1ba0f9c33-11e5-a910-e053-dadaa90a0b85889f8c0e-0a24-4ad1-957f-518333806e18
68788-8996-12021-01-29C16284748780-1ba0f9c33-11e5-a910-e053-dadaa90a0b85889f8c0e-0a24-4ad1-957f-518333806e18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8996-168788899601100 mL in 1 BOTTLE (68788-8996-1) 100 ml2016-02-110000-00-00NoNoCurrent