Amoxicillin

Product NDC
68071-3716
11-digit product format
680713716
Labeler code
68071
Product ID
68071-3716_2646715c-d336-9b32-e063-6394a90a120c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA065255
Marketing category
ANDA
Marketing start
2006-03-29
Substance
AMOXICILLIN
Active strength
875 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
AMOXICILLIN875 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308194

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
68071-3716-2Amoxicillin20 in 1 BOTTLETABLET, COATED201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3716AMOXICILLIN TABLET, COATED [NUCARE PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20241108_26469497-14c2-adb2-e063-6394a90af30a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSN26469497-14c2-adb2-e063-6394a90af30a1
308194amoxicillin 875 MG Oral TabletSCD26469497-14c2-adb2-e063-6394a90af30a1
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY26469497-14c2-adb2-e063-6394a90af30a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3716-26807137160220 TABLET, COATED in 1 BOTTLE (68071-3716-2) 2024-11-06NoNoHistorical