Amoxicillin and Clavulanate Potassium

Product NDC
68071-2448
11-digit product format
680712448
Labeler code
68071
Product ID
68071-2448_c4bd9fbe-b813-6f9a-e053-2a95a90a0108
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
NDA050720
Marketing category
NDA
Marketing start
2019-12-12
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
68071-2448-32023-01-30C16284748780-1f386c64a-3294-0266-e053-dadaa90a7c1ac4bd9fbe-b812-6f9a-e053-2a95a90a0108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2448AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC20210615_c4bd9fbe-b812-6f9a-e053-2a95a90a0108.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2448-3680712448033 TABLET in 1 BOTTLE (68071-2448-3) 3 tablet2021-06-140000-00-00NoNoCurrent