FDA.reportPublic FDA data

Amoxicillin

Product NDC
50090-1086
11-digit product format
500901086
Labeler code
50090
Product ID
50090-1086_6fba8389-62b9-4724-85c4-c1af920a065a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065325
Marketing category
ANDA
Marketing start
2006-06-19
Substance
AMOXICILLIN
Active strength
400 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN400 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308189

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
50090-1086-02023-02-07C16284748780-1f386c649-b7ec-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN FOR ORAL SUSPENSION, USP safely and effectively. See full prescribing information for AMOXICILLIN FOR ORAL SUSPENSION, USP. AMOXICILLIN FOR ORAL SUSPENSION, USP Dye free Initial U.S. Approval: 1974
50090-1086-02023-01-30C16284748780-1f386c649-b7ec-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN FOR ORAL SUSPENSION, USP safely and effectively. See full prescribing information for AMOXICILLIN FOR ORAL SUSPENSION, USP. AMOXICILLIN FOR ORAL SUSPENSION, USP Dye free Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1086-0Amoxicillin75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION759

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1086-0ML - Milliliter50090-10866f294fe3-f4c6-45e4-a04e-c0112f73cc4812018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1086AMOXICILLIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 1 package rows20230222_77265bcd-c05d-443a-84c4-6e5ac75ee42c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN77265bcd-c05d-443a-84c4-6e5ac75ee42c9
308189amoxicillin 80 MG/ML Oral SuspensionSCD77265bcd-c05d-443a-84c4-6e5ac75ee42c9
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY77265bcd-c05d-443a-84c4-6e5ac75ee42c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1086-05009010860075 mL in 1 BOTTLE (50090-1086-0) 75 ml2014-11-280000-00-00NoNoCurrent