FDA.reportPublic FDA data

Amoxicillin

Product NDC
50090-1811
11-digit product format
500901811
Labeler code
50090
Product ID
50090-1811_958ce3c7-af3e-4d05-966b-a470e42348cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-1811-4Amoxicillin56 in 1 BOTTLECAPSULE568
50090-1811-5Amoxicillin4 in 1 BOTTLECAPSULE48
50090-1811-6Amoxicillin20 in 1 BOTTLECAPSULE208
50090-1811-7Amoxicillin100 in 1 BOTTLECAPSULE1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1811-4EA - Each50090-181198f55191-193c-4356-98a3-b67672b45e0412024-08-12
50090-1811-5EA - Each50090-18113ab7fd14-2fe2-44ca-801e-e95cc1bcc26112023-06-06
50090-1811-6EA - Each50090-1811d56d99ba-fe84-425d-bf52-5dbac0cec01712023-06-06
50090-1811-7EA - Each50090-1811a657c7d2-a9d0-42c6-b83b-cb54114ba52d12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1811AMOXICILLIN CAPSULE [A-S MEDICATION SOLUTIONS]8Current NDC, 4 package rows20240418_322feb95-8bd4-440a-bda2-29ee19b11234.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN322feb95-8bd4-440a-bda2-29ee19b112348
308191amoxicillin 500 MG Oral CapsuleSCD322feb95-8bd4-440a-bda2-29ee19b112348
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY322feb95-8bd4-440a-bda2-29ee19b112348

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-1811-45009018110456 CAPSULE in 1 BOTTLE (50090-1811-4) 56 capsule2015-05-07NoNoCurrent
50090-1811-5500901811054 CAPSULE in 1 BOTTLE (50090-1811-5) 4 capsule2015-05-07NoNoCurrent
50090-1811-65009018110620 CAPSULE in 1 BOTTLE (50090-1811-6) 20 capsule2015-05-07NoNoCurrent
50090-1811-750090181107100 CAPSULE in 1 BOTTLE (50090-1811-7) 100 capsule2023-05-09NoNoCurrent