FDA.reportPublic FDA data

Amoxicillin

Product NDC
50090-1595
11-digit product format
500901595
Labeler code
50090
Product ID
50090-1595_a76e72f3-cc65-4fd8-93af-5fc5ffd53946
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065256
Marketing category
ANDA
Marketing start
2005-11-09
Substance
AMOXICILLIN
Active strength
875 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
AMOXICILLIN875 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308194

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
50090-1595-02024-12-24C16284748780-1f386c64a-0819-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
50090-1595-12024-12-24C16284748780-1f386c64a-0819-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
50090-1595-22024-12-24C16284748780-1f386c64a-0819-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
50090-1595-02023-01-30C16284748780-1f386c64a-0819-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
50090-1595-12023-01-30C16284748780-1f386c64a-0819-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974
50090-1595-22023-01-30C16284748780-1f386c64a-0819-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMOXICILLIN TABLETS safely and effectively. See full prescribing information for AMOXICILLIN TABLETS. AMOXICILLIN tablets, for oral use Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1595-0Amoxicillin20 in 1 BOTTLETABLET, FILM COATED2011
50090-1595-1Amoxicillin14 in 1 BOTTLETABLET, FILM COATED1411
50090-1595-2Amoxicillin30 in 1 BOTTLETABLET, FILM COATED3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1595-0EA - Each50090-15955a0fb3e2-aff7-4ffd-9691-6023b7353ac812021-08-05
50090-1595-1EA - Each50090-1595d98063eb-aeb0-4849-8460-4a014eb6c40f12021-09-07
50090-1595-2EA - Each50090-15950ee63419-ad6f-406b-ba3f-b7f74ccba75512021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1595AMOXICILLIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 3 package rows20241226_aaf42367-153e-4525-af5f-f5f1c7d6c559.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSNaaf42367-153e-4525-af5f-f5f1c7d6c55911
308194amoxicillin 875 MG Oral TabletSCDaaf42367-153e-4525-af5f-f5f1c7d6c55911
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSYaaf42367-153e-4525-af5f-f5f1c7d6c55911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1595-05009015950020 TABLET, FILM COATED in 1 BOTTLE (50090-1595-0) 2015-01-050000-00-00NoNoCurrent
50090-1595-15009015950114 TABLET, FILM COATED in 1 BOTTLE (50090-1595-1) 2020-03-120000-00-00NoNoCurrent
50090-1595-25009015950230 TABLET, FILM COATED in 1 BOTTLE (50090-1595-2) 2015-01-050000-00-00NoNoCurrent