FDA.reportPublic FDA data

Amoxicillin

Product NDC
50090-0302
11-digit product format
500900302
Labeler code
50090
Product ID
50090-0302_c5cd7329-898f-49e0-9631-f49f4628ff04
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
50090-0302-42023-03-03C16284748780-19d75b9d0-9b3e-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
50090-0302-52023-03-03C16284748780-19d75b9d0-9b3e-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
50090-0302-62023-03-03C16284748780-19d75b9d0-9b3e-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
50090-0302-72023-03-03C16284748780-19d75b9d0-9b3e-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
50090-0302-42020-01-31C16284748780-19d75b9d0-9b3e-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
50090-0302-52020-01-31C16284748780-19d75b9d0-9b3e-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
50090-0302-62020-01-31C16284748780-19d75b9d0-9b3e-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
50090-0302-72020-01-31C16284748780-19d75b9d0-9b3e-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
50090-0302-0Amoxicillin12 in 1 BOTTLECAPSULE1227
50090-0302-4Amoxicillin56 in 1 BOTTLECAPSULE5627
50090-0302-5Amoxicillin4 in 1 BOTTLECAPSULE427
50090-0302-6Amoxicillin20 in 1 BOTTLECAPSULE2027
50090-0302-7Amoxicillin100 in 1 BOTTLECAPSULE10027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0302-4EA - Each50090-0302f140da4f-1a46-49f3-a07d-3a67636b121912018-08-13
50090-0302-5EA - Each50090-0302d5d0d67d-7117-49c9-b448-8eaf1c19db4412018-08-13
50090-0302-6EA - Each50090-03028600a595-93dc-44f2-ba22-07e2c55ba6cf12018-08-13
50090-0302-7EA - Each50090-03020b51bb78-83d8-41ff-8c37-191054eae64512018-08-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN364f969d-3037-4dff-b04b-304bca27442e27
308191amoxicillin 500 MG Oral CapsuleSCD364f969d-3037-4dff-b04b-304bca27442e27
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY364f969d-3037-4dff-b04b-304bca27442e27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-0302-05009003020012 in 1 BOTTLEHistorical
50090-0302-45009003020456 CAPSULE in 1 BOTTLE (50090-0302-4) 56 capsule2014-11-28NoNoCurrent
50090-0302-5500900302054 CAPSULE in 1 BOTTLE (50090-0302-5) 4 capsule2014-11-28NoNoCurrent
50090-0302-65009003020620 CAPSULE in 1 BOTTLE (50090-0302-6) 20 capsule2014-11-28NoNoCurrent
50090-0302-750090030207100 CAPSULE in 1 BOTTLE (50090-0302-7) 100 capsule2014-11-28NoNoCurrent