FDA.reportPublic FDA data

Amoxicillin

Product NDC
60687-798
11-digit product format
606870798
Labeler code
60687
Product ID
60687-798_4ee4fb77-9fd6-ea5e-e063-6394a90a0d9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA065256
Marketing category
ANDA
Marketing start
2025-03-25
Marketing end
2026-12-31
Substance
AMOXICILLIN
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN500 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
60687-798-25Amoxicillin30 in 1 CARTONTABLET, FILM COATED304
60687-798-95Amoxicillin1 in 1 BLISTER PACKTABLET, FILM COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-798-25EA - Each60687-79883301110-b311-4b10-a115-f0f0036a982412025-03-04
60687-798-95EA - Each60687-79840d799f1-3735-4e9a-9a3a-9e008817c04612025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-798AMOXICILLIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2Current NDC, 2 package rows20250221_d339ea0f-8797-460f-a3b7-b8455c250366.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308192amoxicillin 500 MG Oral TabletPSNd339ea0f-8797-460f-a3b7-b8455c2503664
308194amoxicillin 875 MG Oral TabletPSNd339ea0f-8797-460f-a3b7-b8455c2503664
308192amoxicillin 500 MG Oral TabletSCDd339ea0f-8797-460f-a3b7-b8455c2503664
308194amoxicillin 875 MG Oral TabletSCDd339ea0f-8797-460f-a3b7-b8455c2503664
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSYd339ea0f-8797-460f-a3b7-b8455c2503664

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-798-256068707982530 BLISTER PACK in 1 CARTON (60687-798-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-798-95) 30 blister pack2025-03-252026-12-31NoNoHistorical
60687-798-95606870798951 in 1 BLISTER PACKHistorical