FDA.reportPublic FDA data

Amoxicillin

Product NDC
50090-1807
11-digit product format
500901807
Labeler code
50090
Product ID
50090-1807_d4369872-edfd-4630-9002-e949be7bae52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA061931
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
250 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1807-02023-01-30C16284748780-1f386c64a-084b-0266-e053-dadaa90a7c1aThese 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
50090-1807-0Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1807-0ML - Milliliter50090-18078029a1b0-8276-4ee3-ab85-0c83f1f7535d12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1807AMOXICILLIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]5Legacy NDC, 1 package rows20210226_1d6d8372-dd7f-42a0-a447-fd699beb0aab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN1d6d8372-dd7f-42a0-a447-fd699beb0aab5
239191amoxicillin 50 MG/ML Oral SuspensionSCD1d6d8372-dd7f-42a0-a447-fd699beb0aab5
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY1d6d8372-dd7f-42a0-a447-fd699beb0aab5
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY1d6d8372-dd7f-42a0-a447-fd699beb0aab5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1807-050090180700100 mL in 1 BOTTLE (50090-1807-0) 100 ml2015-05-070000-00-00NoNoCurrent