FDA.reportPublic FDA data

AMOXICILLIN

Product NDC
42571-234
11-digit product format
425710234
Labeler code
42571
Product ID
42571-234_238f9a44-0678-eb7c-e063-6394a90a4c73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA207471
Marketing category
ANDA
Marketing start
2022-11-01
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
Rxcui308182, 308191

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
42571-234-01AMOXICILLIN100 in 1 BOTTLECAPSULE1004
42571-234-05AMOXICILLIN500 in 1 BOTTLECAPSULE5004
42571-234-10AMOXICILLIN1000 in 1 BOTTLECAPSULE10004
42571-234-30AMOXICILLIN30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-234-01EA - Each42571-234bfde63d2-17fb-47c1-96be-34b880413c1a12025-12-16
42571-234-05EA - Each42571-234ec6c3dee-2d48-46ac-ae77-1b456f05227212023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-234AMOXICILLIN (AMOXICILLIN) CAPSULE [MICRO LABS LIMITED]4Current NDC, Legacy NDC, 4 package rows20241004_42f935ca-45ba-4b3e-8b40-9b2d4eb56281.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN42f935ca-45ba-4b3e-8b40-9b2d4eb562814
308191amoxicillin 500 MG Oral CapsulePSN42f935ca-45ba-4b3e-8b40-9b2d4eb562814
308182amoxicillin 250 MG Oral CapsuleSCD42f935ca-45ba-4b3e-8b40-9b2d4eb562814
308191amoxicillin 500 MG Oral CapsuleSCD42f935ca-45ba-4b3e-8b40-9b2d4eb562814
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY42f935ca-45ba-4b3e-8b40-9b2d4eb562814
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY42f935ca-45ba-4b3e-8b40-9b2d4eb562814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-234-0142571023401100 CAPSULE in 1 BOTTLE (42571-234-01) 100 capsule2022-11-010000-00-00NoNoCurrent
42571-234-0542571023405500 CAPSULE in 1 BOTTLE (42571-234-05) 500 capsule2022-11-010000-00-00NoNoCurrent
42571-234-10425710234101000 CAPSULE in 1 BOTTLE (42571-234-10) 1000 capsule2022-11-010000-00-00NoNoCurrent
42571-234-304257102343030 CAPSULE in 1 BOTTLE (42571-234-30) 30 capsule2022-11-010000-00-00NoNoCurrent