FDA.reportPublic FDA data

Amoxicillin

Product NDC
51655-156
11-digit product format
516550156
Labeler code
51655
Product ID
51655-156_2abd833e-e8e5-cb77-e063-6294a90ac0ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA065271
Marketing category
ANDA
Marketing start
2014-11-06
Marketing end
2026-10-31
Substance
AMOXICILLIN
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin

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
51655-156-212023-07-18C16284748780-19d75b9d0-bd2e-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
51655-156-212020-01-31C16284748780-19d75b9d0-bd2e-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
51655-156-20Amoxicillin20 in 1 BOTTLE, PLASTICCAPSULE203
51655-156-21Amoxicillin21 in 1 BOTTLE, DISPENSINGCAPSULE213
51655-156-51Amoxicillin40 in 1 BOTTLE, PLASTICCAPSULE403
51655-156-52Amoxicillin30 in 1 BOTTLE, PLASTICCAPSULE303
51655-156-84Amoxicillin14 in 1 BOTTLE, PLASTICCAPSULE143

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-156AMOXICILLIN CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 5 package rows20250104_26114563-c719-46da-b976-3e4271533f28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN26114563-c719-46da-b976-3e4271533f283
308191amoxicillin 500 MG Oral CapsuleSCD26114563-c719-46da-b976-3e4271533f283
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY26114563-c719-46da-b976-3e4271533f283

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-156-205165501562020 CAPSULE in 1 BOTTLE, PLASTIC (51655-156-20) 20 capsule2023-05-012026-09-30NoNoHistorical
51655-156-215165501562121 CAPSULE in 1 BOTTLE, DISPENSING (51655-156-21) 21 capsule2014-11-062026-10-31NoNoHistorical
51655-156-515165501565140 in 1 BOTTLE, PLASTICHistorical
51655-156-525165501565230 CAPSULE in 1 BOTTLE, PLASTIC (51655-156-52) 30 capsule2023-05-012026-10-31NoNoHistorical
51655-156-845165501568414 CAPSULE in 1 BOTTLE, PLASTIC (51655-156-84) 14 capsule2023-05-182026-09-30NoNoHistorical