FDA.reportPublic FDA data

Amoxicillin

Product NDC
50090-0304
11-digit product format
500900304
Labeler code
50090
Product ID
50090-0304_da69ba1a-a83e-4a3d-bc15-2642b863de31
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
50090-0304-02023-03-02C16284748780-19d75b9d0-16ff-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
50090-0304-02020-01-31C16284748780-19d75b9d0-16ff-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
50090-0304-0Amoxicillin30 in 1 BOTTLECAPSULE3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0304-0EA - Each50090-0304a505b8b4-800d-4f6e-850d-24efdc5feb2012018-08-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSNfd071263-b750-4831-9fc5-de112a5f685b16
308191amoxicillin 500 MG Oral CapsuleSCDfd071263-b750-4831-9fc5-de112a5f685b16
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYfd071263-b750-4831-9fc5-de112a5f685b16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-0304-05009003040030 CAPSULE in 1 BOTTLE (50090-0304-0) 30 capsule2014-11-28NoNoHistorical