FDA.reportPublic FDA data

Amoxicillin

Product NDC
53217-312
11-digit product format
532170312
Labeler code
53217
Product ID
53217-312_9b004e12-2f2e-4f3c-bdff-788630bf0f41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA061931
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
125 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-312-012020-01-31C16284748780-19d75b9cf-d2ec-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES, AMOXICILLIN FOR ORAL SUSPENSION, and AMOXICILLIN TABLETS (CHEWABLE) safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES, AMOXICILLIN FOR ORAL SUSPENSION, and AMOXICILLIN TABLETS (CHEWABLE). AMOXICILLIN capsules, AMOXICILLIN for oral suspension, and AMOXICILLIN tablets (chewable) for oral use Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-312-01Amoxicillin150 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-312-01ML - Milliliter53217-312ee7e76f6-f735-4cf2-a8d3-342ba21311a512017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-312AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20170601_8c001aa8-ee79-4aea-ac67-5eac33319342.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSN8c001aa8-ee79-4aea-ac67-5eac333193421
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN8c001aa8-ee79-4aea-ac67-5eac333193421
313797amoxicillin 25 MG/ML Oral SuspensionSCD8c001aa8-ee79-4aea-ac67-5eac333193421
239191amoxicillin 50 MG/ML Oral SuspensionSCD8c001aa8-ee79-4aea-ac67-5eac333193421
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSY8c001aa8-ee79-4aea-ac67-5eac333193421
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY8c001aa8-ee79-4aea-ac67-5eac333193421
313797amoxicillin 125 MG per 5 ML Oral SuspensionSY8c001aa8-ee79-4aea-ac67-5eac333193421
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY8c001aa8-ee79-4aea-ac67-5eac333193421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53217-312-0153217031201150 mL in 1 BOTTLE150 mlHistorical