FDA.reportPublic FDA data

Amoxicillin

Product NDC
50090-0301
11-digit product format
500900301
Labeler code
50090
Product ID
50090-0301_7ffa042b-2350-43cf-89ee-1a5bfe0760f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065291
Marketing category
ANDA
Marketing start
2007-03-01
Substance
AMOXICILLIN
Active strength
500 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
AMOXICILLIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308191

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
50090-0301-02023-03-03C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-12023-03-03C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-22023-03-03C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-52023-03-03C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-72023-03-03C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-82023-03-03C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-02023-01-30C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-12023-01-30C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-22023-01-30C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-52023-01-30C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-72023-01-30C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-82023-01-30C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-02021-04-17C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-12021-04-17C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-22021-04-17C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-52021-04-17C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-72021-04-17C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-82021-04-17C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-02020-01-31C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-12020-01-31C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-22020-01-31C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-52020-01-31C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-72020-01-31C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974
50090-0301-82020-01-31C16284748780-19d75b9cf-dfbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0301-0Amoxicillin30 in 1 BOTTLECAPSULE3038
50090-0301-1Amoxicillin40 in 1 BOTTLECAPSULE4038
50090-0301-2Amoxicillin21 in 1 BOTTLECAPSULE2138
50090-0301-5Amoxicillin15 in 1 BOTTLECAPSULE1538
50090-0301-7Amoxicillin10 in 1 BOTTLECAPSULE1038
50090-0301-8Amoxicillin9 in 1 BOTTLECAPSULE938

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSNb988349d-2198-4dbb-a231-9ba37262ce2838
308191amoxicillin 500 MG Oral CapsuleSCDb988349d-2198-4dbb-a231-9ba37262ce2838
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYb988349d-2198-4dbb-a231-9ba37262ce2838

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0301-05009003010030 CAPSULE in 1 BOTTLE (50090-0301-0) 30 capsule2014-11-280000-00-00NoNoCurrent
50090-0301-15009003010140 CAPSULE in 1 BOTTLE (50090-0301-1) 40 capsule2014-11-280000-00-00NoNoCurrent
50090-0301-25009003010221 CAPSULE in 1 BOTTLE (50090-0301-2) 21 capsule2014-11-280000-00-00NoNoCurrent
50090-0301-55009003010515 CAPSULE in 1 BOTTLE (50090-0301-5) 15 capsule2014-11-280000-00-00NoNoCurrent
50090-0301-75009003010710 CAPSULE in 1 BOTTLE (50090-0301-7) 10 capsule2017-12-080000-00-00NoNoCurrent
50090-0301-8500900301089 CAPSULE in 1 BOTTLE (50090-0301-8) 9 capsule2014-11-280000-00-00NoNoCurrent