FDA.reportPublic FDA data

Amoxicillin

Product NDC
72789-254
11-digit product format
727890254
Labeler code
72789
Product ID
72789-254_40ad4248-bc9d-d6b4-e063-6294a90acd79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA065291
Marketing category
ANDA
Marketing start
2007-03-01
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
72789-254-21Amoxicillin21 in 1 BOTTLE, PLASTICCAPSULE2121
72789-254-60Amoxicillin60 in 1 BOTTLE, PLASTICCAPSULE6021
72789-254-30Amoxicillin30 in 1 BOTTLE, PLASTICCAPSULE3020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-254-30EA - Each72789-254349b715f-f621-497b-bf68-f2220ebeb6b712022-08-04
72789-254-60EA - Each72789-2549b1edee6-9be6-42b8-b229-c8c1689b2f9b12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-254AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 2 package rows20240123_039d2677-b04f-436c-e063-6294a90ac519.zip
72789-254AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]19Current NDC, Legacy NDC, 1 package rows20240906_18a4f555-a537-4c40-9bb2-dc3bd782fa27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN039d2677-b04f-436c-e063-6294a90ac51921
308191amoxicillin 500 MG Oral CapsuleSCD039d2677-b04f-436c-e063-6294a90ac51921
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY039d2677-b04f-436c-e063-6294a90ac51921
308191amoxicillin 500 MG Oral CapsulePSN18a4f555-a537-4c40-9bb2-dc3bd782fa2720
308191amoxicillin 500 MG Oral CapsuleSCD18a4f555-a537-4c40-9bb2-dc3bd782fa2720
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY18a4f555-a537-4c40-9bb2-dc3bd782fa2720

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-254-217278902542121 CAPSULE in 1 BOTTLE, PLASTIC (72789-254-21) 21 capsule2023-08-23NoNoCurrent
72789-254-307278902543030 CAPSULE in 1 BOTTLE, PLASTIC (72789-254-30) 30 capsule2022-06-290000-00-00NoNoCurrent
72789-254-607278902546060 CAPSULE in 1 BOTTLE, PLASTIC (72789-254-60) 60 capsule2024-01-22NoNoCurrent