FDA.reportPublic FDA data

Amoxicillin

Product NDC
82868-056
11-digit product format
828680056
Labeler code
82868
Product ID
82868-056_47aa764d-1cf2-b5a9-e063-6394a90a237c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA065271
Marketing category
ANDA
Marketing start
2024-05-30
Substance
AMOXICILLIN
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82868-056-14Amoxicillin14 in 1 BOTTLE, PLASTICCAPSULE143
82868-056-20Amoxicillin20 in 1 BOTTLE, PLASTICCAPSULE203
82868-056-21Amoxicillin21 in 1 BOTTLE, PLASTICCAPSULE213
82868-056-30Amoxicillin30 in 1 BOTTLE, PLASTICCAPSULE303
82868-056-40Amoxicillin40 in 1 BOTTLE, PLASTICCAPSULE403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82868-056AMOXICILLIN CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 5 package rows20241116_1d0d8bc4-137e-ef10-e063-6294a90acf62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN1d0d8bc4-137e-ef10-e063-6294a90acf623
308191amoxicillin 500 MG Oral CapsuleSCD1d0d8bc4-137e-ef10-e063-6294a90acf623
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY1d0d8bc4-137e-ef10-e063-6294a90acf623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82868-056-148286800561414 CAPSULE in 1 BOTTLE, PLASTIC (82868-056-14) 14 capsule2024-10-31NoNoHistorical
82868-056-208286800562020 CAPSULE in 1 BOTTLE, PLASTIC (82868-056-20) 20 capsule2024-05-30NoNoHistorical
82868-056-218286800562121 CAPSULE in 1 BOTTLE, PLASTIC (82868-056-21) 21 capsule2024-09-17NoNoHistorical
82868-056-308286800563030 CAPSULE in 1 BOTTLE, PLASTIC (82868-056-30) 30 capsule2024-09-17NoNoHistorical
82868-056-408286800564040 CAPSULE in 1 BOTTLE, PLASTIC (82868-056-40) 40 capsule2025-02-26NoNoHistorical