FDA.reportPublic FDA data

Amoxicillin

Product NDC
68071-2604
11-digit product format
680712604
Labeler code
68071
Product ID
68071-2604_d3c325a1-cdd7-b27c-e053-2a95a90aa534
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065334
Marketing category
ANDA
Marketing start
2006-12-28
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
400 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2604-52025-01-30C16284748780-1f386c64a-2889-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN FOR ORAL SUSPENSION. AMOXICILLIN for oral suspension, for oral use Initial U.S. Approval: 1974
68071-2604-52023-07-14C16284748780-1f386c64a-2889-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN FOR ORAL SUSPENSION. AMOXICILLIN for oral suspension, for oral use Initial U.S. Approval: 1974
68071-2604-52023-01-30C16284748780-1f386c64a-2889-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN FOR ORAL SUSPENSION. AMOXICILLIN for oral suspension, for oral use Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2604-5Amoxicillin75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION752

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2604AMOXICILLIN POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20230715_d3c32596-2913-7a49-e053-2a95a90a00a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSNd3c32596-2913-7a49-e053-2a95a90a00a02
308189amoxicillin 80 MG/ML Oral SuspensionSCDd3c32596-2913-7a49-e053-2a95a90a00a02
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSYd3c32596-2913-7a49-e053-2a95a90a00a02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2604-56807126040575 mL in 1 BOTTLE (68071-2604-5) 75 ml2021-12-220000-00-00NoNoCurrent