FDA.reportPublic FDA data

Amoxicillin

Product NDC
50090-0455
11-digit product format
500900455
Labeler code
50090
Product ID
50090-0455_845fc154-9902-4853-9aac-81a2d9c11799
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA064013
Marketing category
ANDA
Marketing start
1993-01-01
Substance
AMOXICILLIN
Active strength
250 mg/1
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
AMOXICILLIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui239191, 313797, 598025

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
50090-0455-02023-02-07C16284748780-19d75b9d0-ecfb-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
50090-0455-02023-01-30C16284748780-19d75b9d0-ecfb-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
50090-0455-02021-06-10C16284748780-19d75b9d0-ecfb-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
50090-0455-02020-01-31C16284748780-19d75b9d0-ecfb-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
50090-0455-0Amoxicillin30 in 1 BOTTLETABLET, CHEWABLE3029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0455-0EA - Each50090-0455221efa8c-76ee-4ef5-bef8-c85bd60bdb8312018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0455AMOXICILLIN TABLET, CHEWABLE AMOXICILLIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]29Current NDC, Legacy NDC, 1 package rows20240510_63b395ca-f0ea-4429-b8aa-18f495596e4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSN63b395ca-f0ea-4429-b8aa-18f495596e4d29
598025amoxicillin 250 MG Chewable TabletPSN63b395ca-f0ea-4429-b8aa-18f495596e4d29
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN63b395ca-f0ea-4429-b8aa-18f495596e4d29
313797amoxicillin 25 MG/ML Oral SuspensionSCD63b395ca-f0ea-4429-b8aa-18f495596e4d29
598025amoxicillin 250 MG Chewable TabletSCD63b395ca-f0ea-4429-b8aa-18f495596e4d29
239191amoxicillin 50 MG/ML Oral SuspensionSCD63b395ca-f0ea-4429-b8aa-18f495596e4d29
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSY63b395ca-f0ea-4429-b8aa-18f495596e4d29
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY63b395ca-f0ea-4429-b8aa-18f495596e4d29
313797amoxicillin 125 MG per 5 ML Oral SuspensionSY63b395ca-f0ea-4429-b8aa-18f495596e4d29
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY63b395ca-f0ea-4429-b8aa-18f495596e4d29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0455-05009004550030 TABLET, CHEWABLE in 1 BOTTLE (50090-0455-0) 2014-11-280000-00-00NoNoCurrent