FDA.reportPublic FDA data

Amoxicillin

Product NDC
50090-1347
11-digit product format
500901347
Labeler code
50090
Product ID
50090-1347_8ad02473-82e5-42cf-8406-53ef7d6934f8
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
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
50090-1347-02023-02-07C16284748780-1f386c649-d126-0266-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
50090-1347-02023-01-30C16284748780-1f386c649-d126-0266-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
50090-1347-0Amoxicillin50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION5016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1347-0ML - Milliliter50090-134783273b29-aaa6-4884-9542-8556502cf0fd12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1347AMOXICILLIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 1 package rows20230911_156ef8e9-b6e4-4512-865f-7139c90c8f9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN156ef8e9-b6e4-4512-865f-7139c90c8f9b16
308189amoxicillin 80 MG/ML Oral SuspensionSCD156ef8e9-b6e4-4512-865f-7139c90c8f9b16
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY156ef8e9-b6e4-4512-865f-7139c90c8f9b16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1347-05009013470050 mL in 1 BOTTLE (50090-1347-0) 50 ml2014-11-280000-00-00NoNoCurrent