FDA.reportPublic FDA data

Amoxicillin and Clavulanate Potassium

Product NDC
50436-8675
11-digit product format
504368675
Labeler code
50436
Product ID
50436-8675_2e43a98c-a38c-428b-bbb0-ed4baa8ac300
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin and Clavulanate Potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA065162
Marketing category
ANDA
Marketing start
2004-09-23
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
600 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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
ebb3e917-326a-9e18-0354-a19c9f63a2f3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-8675-12021-01-29C16284748780-1ba0f9c33-4ae7-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amoxicillin and clavulanate potassium for oral suspension USP safely and effectively. See full prescribing information for amoxicillin and clavulanate potassium for oral suspension USP . AMOXICILLIN and CLAVULANATE POTASSIUM for oral suspension USP powder for oral suspension Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspensi

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-8675-1Amoxicillin and Clavulanate Potassium125 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-8675AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [UNIT DOSE SERVICES]1Legacy NDC, 1 package rows20161029_0f8b17fd-a8bd-433b-8e25-8c8903f8e6b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617993amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral SuspensionPSN0f8b17fd-a8bd-433b-8e25-8c8903f8e6b01
617993amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral SuspensionSCD0f8b17fd-a8bd-433b-8e25-8c8903f8e6b01
617993amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral SuspensionSY0f8b17fd-a8bd-433b-8e25-8c8903f8e6b01
617993amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral SuspensionSY0f8b17fd-a8bd-433b-8e25-8c8903f8e6b01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50436-8675-150436867501125 mL in 1 BOTTLE125 mlHistorical