Amoxicillin

Product NDC
67046-0127
11-digit product format
670460127
Labeler code
67046
Product ID
67046-0127_50fff3cc-9374-b781-e063-6394a90a7920
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Coupler LLC
Application
ANDA064076
Marketing category
ANDA
Marketing start
2026-05-04
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
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
67046-0127-3Amoxicillin30 in 1 BLISTER PACKCAPSULE301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN50fff2b8-8bf1-ff46-e063-6394a90a92131
308182amoxicillin 250 MG Oral CapsuleSCD50fff2b8-8bf1-ff46-e063-6394a90a92131
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY50fff2b8-8bf1-ff46-e063-6394a90a92131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-0127-36704601270330 CAPSULE in 1 BLISTER PACK (67046-0127-3) 30 capsule2026-05-04NoNoCurrent