Amoxicillin and Clavulanate Potassium

Product NDC
68071-2435
11-digit product format
680712435
Labeler code
68071
Product ID
68071-2435_c3e060b7-883e-6562-e053-2995a90a55c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065096
Marketing category
ANDA
Marketing start
2002-10-31
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
68071-2435-22023-01-30C16284748780-1f386c64a-1d90-0266-e053-dadaa90a7c1ac3e12911-5ab6-d950-e053-2a95a90acec5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2435AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC20210605_c3e12911-5ab6-d950-e053-2a95a90acec5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2435-26807124350220 TABLET, FILM COATED in 1 BOTTLE (68071-2435-2) 2021-06-030000-00-00NoNoCurrent