Amoxicillin and Clavulanate Potassium

Product NDC
68071-5152
11-digit product format
680715152
Labeler code
68071
Product ID
68071-5152_bbf5ba02-2555-6671-e053-2995a90a8c3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065191
Marketing category
ANDA
Marketing start
2007-12-01
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANIC ACID
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
68071-5152-72024-06-20C16284748780-1f386c649-fc52-0266-e053-dadaa90a7c1a9c465dca-f8fa-91d4-e053-2a95a90a847b
68071-5152-72023-01-30C16284748780-1f386c649-fc52-0266-e053-dadaa90a7c1a9c465dca-f8fa-91d4-e053-2a95a90a847b

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5152-76807151520775 mL in 1 BOTTLE (68071-5152-7) 75 ml2020-01-160000-00-00NoNoCurrent