Amoxicillin

Product NDC
68999-825
11-digit product format
689990825
Labeler code
68999
Product ID
68999-825_46911108-ba5e-8cba-e063-6294a90adccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell Governmental & Specialty RX, LLC
Application
ANDA062058
Marketing category
ANDA
Marketing start
1978-08-03
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
Rxcui308182, 308191

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
68999-825-01Amoxicillin100 in 1 BOTTLECAPSULE1005
68999-825-60Amoxicillin60 in 1 BOTTLECAPSULE605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68999-825AMOXICILLIN CAPSULE [CHARTWELL GOVERNMENTAL & SPECIALTY RX, LLC]4Current NDC, Legacy NDC, 2 package rows20240605_f9062321-ffb3-42e8-8f98-453cd30f5282.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSNf9062321-ffb3-42e8-8f98-453cd30f52825
308191amoxicillin 500 MG Oral CapsulePSNf9062321-ffb3-42e8-8f98-453cd30f52825
308182amoxicillin 250 MG Oral CapsuleSCDf9062321-ffb3-42e8-8f98-453cd30f52825
308191amoxicillin 500 MG Oral CapsuleSCDf9062321-ffb3-42e8-8f98-453cd30f52825
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYf9062321-ffb3-42e8-8f98-453cd30f52825
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYf9062321-ffb3-42e8-8f98-453cd30f52825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68999-825-0168999082501100 CAPSULE in 1 BOTTLE (68999-825-01) 100 capsule2022-06-240000-00-00NoNoCurrent
68999-825-606899908256060 CAPSULE in 1 BOTTLE (68999-825-60) 60 capsule2022-06-240000-00-00NoNoCurrent