Amoxicillin

Product NDC
43063-915
11-digit product format
430630915
Labeler code
43063
Product ID
43063-915_415d8f3c-a757-c1e3-e063-6294a90ab7b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, 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
43063-915-30Amoxicillin30 in 1 BOTTLE, PLASTICCAPSULE3025

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-915AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 1 package rows20240704_987786a1-d748-4b42-abb5-62a2f38ef195.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN987786a1-d748-4b42-abb5-62a2f38ef19525
308191amoxicillin 500 MG Oral CapsuleSCD987786a1-d748-4b42-abb5-62a2f38ef19525
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY987786a1-d748-4b42-abb5-62a2f38ef19525

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-915-304306309153030 CAPSULE in 1 BOTTLE, PLASTIC (43063-915-30) 30 capsule2018-12-120000-00-00NoNoCurrent