Amoxicillin

Product NDC
63629-7585
11-digit product format
636297585
Labeler code
63629
Product ID
63629-7585_23891944-87f3-47dc-b49a-202595a22a96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA064076
Marketing category
ANDA
Marketing start
1994-09-30
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
63629-7585-1Amoxicillin21 in 1 BOTTLECAPSULE215

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7585AMOXICILLIN CAPSULE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 1 package rows20240601_260a3a79-9dd6-4c4b-82ec-f8050346e886.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN260a3a79-9dd6-4c4b-82ec-f8050346e8865
308191amoxicillin 500 MG Oral CapsuleSCD260a3a79-9dd6-4c4b-82ec-f8050346e8865
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY260a3a79-9dd6-4c4b-82ec-f8050346e8865

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7585-16362975850121 CAPSULE in 1 BOTTLE (63629-7585-1) 21 capsule2021-12-280000-00-00NoNoCurrent