Amoxicillin and Clavulanate Potassium

Product NDC
69043-027
11-digit product format
690430027
Labeler code
69043
Product ID
69043-027_90f51e45-8901-49d3-a7d1-554e24abe594
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Cronus Pharma LLC
Application
ANDA209371
Marketing category
ANDA
Marketing start
2019-04-19
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
250 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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69043-027-18Carprofen180 in 1 BOTTLETABLET, CHEWABLE1805
69043-027-60Carprofen60 in 1 BOTTLETABLET, CHEWABLE605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69043-027CARPROFEN TABLET, CHEWABLE [CRONUS PHARMA LLC]4Legacy NDC, 2 package rows20240725_3c088145-0f3e-4fb6-9b46-d53344de1b82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860125carprofen 100 MG Chewable TabletPSN3c088145-0f3e-4fb6-9b46-d53344de1b825
847142carprofen 25 MG Chewable TabletPSN3c088145-0f3e-4fb6-9b46-d53344de1b825
847147carprofen 75 MG Chewable TabletPSN3c088145-0f3e-4fb6-9b46-d53344de1b825
860125carprofen 100 MG Chewable TabletSCD3c088145-0f3e-4fb6-9b46-d53344de1b825
847142carprofen 25 MG Chewable TabletSCD3c088145-0f3e-4fb6-9b46-d53344de1b825
847147carprofen 75 MG Chewable TabletSCD3c088145-0f3e-4fb6-9b46-d53344de1b825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69043-027-1869043002718180 in 1 BOTTLEHistorical
69043-027-606904300276060 in 1 BOTTLEHistorical