Amoxicillin

Product NDC
82868-072
11-digit product format
828680072
Labeler code
82868
Product ID
82868-072_4ecef9a1-7d9e-0d8c-e063-6394a90af452
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA064076
Marketing category
ANDA
Marketing start
2025-02-18
Substance
AMOXICILLIN
Active strength
250 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
AMOXICILLIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308182

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
82868-072-30Amoxicillin30 in 1 BOTTLE, PLASTICCAPSULE301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN4ecefd37-9847-1d93-e063-6394a90a19f01
308182amoxicillin 250 MG Oral CapsuleSCD4ecefd37-9847-1d93-e063-6394a90a19f01
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY4ecefd37-9847-1d93-e063-6394a90a19f01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82868-072-308286800723030 CAPSULE in 1 BOTTLE, PLASTIC (82868-072-30) 30 capsule2025-02-18NoNoHistorical