Amoxicillin

Product NDC
76420-508
11-digit product format
764200508
Labeler code
76420
Product ID
76420-508_ec75f13d-67a5-ddb2-e053-2a95a90a1b69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA065271
Marketing category
ANDA
Marketing start
2005-11-09
Substance
AMOXICILLIN
Active strength
500 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
AMOXICILLIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308191

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
76420-508-50Amoxicillin50 in 1 BOTTLECAPSULE501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-508-50EA - Each76420-5087eb10a6b-2cd0-48e6-ad74-f76c2390045a12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-508AMOXICILLIN CAPSULE [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 1 package rows20221103_fe9e12de-9be9-4211-9a58-c7ecd9e838d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSNfe9e12de-9be9-4211-9a58-c7ecd9e838d51
308191amoxicillin 500 MG Oral CapsuleSCDfe9e12de-9be9-4211-9a58-c7ecd9e838d51
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYfe9e12de-9be9-4211-9a58-c7ecd9e838d51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-508-507642005085050 CAPSULE in 1 BOTTLE (76420-508-50) 50 capsule2022-11-020000-00-00NoNoCurrent