Amoxicillin

Product NDC
68071-1826
11-digit product format
680711826
Labeler code
68071
Product ID
68071-1826_db73fed1-bad1-1cab-e053-2a95a90a75b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065378
Marketing category
ANDA
Marketing start
2007-03-26
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
2023-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1826-5Amoxicillin50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1826AMOXICILLIN POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220331_db73ebaa-9897-7505-e053-2a95a90a0c62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSNdb73ebaa-9897-7505-e053-2a95a90a0c621
308189amoxicillin 80 MG/ML Oral SuspensionSCDdb73ebaa-9897-7505-e053-2a95a90a0c621
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSYdb73ebaa-9897-7505-e053-2a95a90a0c621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-1826-56807118260550 mL in 1 BOTTLE (68071-1826-5) 50 ml2022-03-300000-00-00NoNoCurrent