Amoxicillin

Product NDC
70518-4279
11-digit product format
705184279
Labeler code
70518
Product ID
70518-4279_4019ca10-7739-0452-e063-6294a90abd53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065291
Marketing category
ANDA
Marketing start
2025-02-06
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
70518-4279-0Amoxicillin100 in 1 BOXCAPSULE1002
70518-4279-1Amoxicillin1 in 1 POUCHCAPSULE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4279AMOXICILLIN CAPSULE [REMEDYREPACK INC.]1Current NDC, 2 package rows20250209_b6ea2f81-aee6-4c88-b681-50eb28e80a86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSNb6ea2f81-aee6-4c88-b681-50eb28e80a862
308191amoxicillin 500 MG Oral CapsuleSCDb6ea2f81-aee6-4c88-b681-50eb28e80a862
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYb6ea2f81-aee6-4c88-b681-50eb28e80a862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4279-070518427900100 POUCH in 1 BOX (70518-4279-0) / 1 CAPSULE in 1 POUCH (70518-4279-1) 100 pouch2025-02-06NoNoHistorical
70518-4279-1705184279011 in 1 POUCHHistorical