FDA.reportPublic FDA data

Amoxicillin

Product NDC
68071-4741
11-digit product format
680714741
Labeler code
68071
Product ID
68071-4741_2d7cf900-c6dd-6484-e063-6294a90a21b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA061926
Marketing category
ANDA
Marketing start
1990-09-30
Substance
AMOXICILLIN
Active strength
250 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
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
68071-4741-3Amoxicillin30 in 1 BOTTLECAPSULE307
68071-4741-4Amoxicillin40 in 1 BOTTLECAPSULE407

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4741AMOXICILLIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 2 package rows20250209_80a04b8a-110e-0aea-e053-2a91aa0ad057.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN80a04b8a-110e-0aea-e053-2a91aa0ad0577
308182amoxicillin 250 MG Oral CapsuleSCD80a04b8a-110e-0aea-e053-2a91aa0ad0577
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY80a04b8a-110e-0aea-e053-2a91aa0ad0577

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4741-36807147410330 CAPSULE in 1 BOTTLE (68071-4741-3) 30 capsule2019-01-290000-00-00NoNoCurrent
68071-4741-46807147410440 CAPSULE in 1 BOTTLE (68071-4741-4) 40 capsule2019-01-290000-00-00NoNoCurrent