FDA.reportPublic FDA data

Amoxicillin

Product NDC
76420-003
11-digit product format
764200003
Labeler code
76420
Product ID
76420-003_203ead37-92bb-9348-e063-6294a90ab111
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA065256
Marketing category
ANDA
Marketing start
2005-11-09
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
Rxcui308192, 308194

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-003-01Amoxicillin100 in 1 BOTTLETABLET, FILM COATED1002
76420-003-20Amoxicillin20 in 1 BOTTLETABLET, FILM COATED202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-003-20EA - Each76420-003a0cf5130-92c1-4428-af81-6cb8d56f15a712022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-003AMOXICILLIN TABLET, FILM COATED [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 2 package rows20240824_a18751fa-6202-4ae2-950a-a3f1dc9a8afd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308192amoxicillin 500 MG Oral TabletPSNa18751fa-6202-4ae2-950a-a3f1dc9a8afd2
308194amoxicillin 875 MG Oral TabletPSNa18751fa-6202-4ae2-950a-a3f1dc9a8afd2
308192amoxicillin 500 MG Oral TabletSCDa18751fa-6202-4ae2-950a-a3f1dc9a8afd2
308194amoxicillin 875 MG Oral TabletSCDa18751fa-6202-4ae2-950a-a3f1dc9a8afd2
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSYa18751fa-6202-4ae2-950a-a3f1dc9a8afd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-003-0176420000301100 TABLET, FILM COATED in 1 BOTTLE (76420-003-01) 2024-08-21NoNoCurrent
76420-003-207642000032020 TABLET, FILM COATED in 1 BOTTLE (76420-003-20) 2024-08-210000-00-00NoNoCurrent