Amoxicillin and Clavulanate Potassium

Product NDC
68071-5208
11-digit product format
680715208
Labeler code
68071
Product ID
68071-5208_d7735e06-3217-e125-e053-2a95a90a93d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5208-12022-02-07C16284748780-1d6a99b39-5358-a426-e053-dadaa90af4c2a1004cd2-f843-1c87-e053-2995a90a41c8
68071-5208-12022-01-28C16284748780-1d6a99b39-5358-a426-e053-dadaa90af4c2a1004cd2-f843-1c87-e053-2995a90a41c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5208-168071520801100 mL in 1 BOTTLE (68071-5208-1) 100 ml2020-03-160000-00-00NoNoCurrent