FDA.reportPublic FDA data

AMOXICILLIN

Product NDC
81964-205
11-digit product format
819640205
Labeler code
81964
Product ID
81964-205_3596a066-4a99-1e8b-e063-6294a90a7346
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
USAntibiotics, LLC
Application
ANDA062216
Marketing category
ANDA
Marketing start
2022-09-15
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
81964-205-01AMOXICILLIN100 in 1 BOTTLECAPSULE1005
81964-205-05AMOXICILLIN500 in 1 BOTTLECAPSULE5005
81964-205-10AMOXICILLIN100 in 1 BOTTLECAPSULE1005
81964-205-60AMOXICILLIN60 in 1 BOTTLECAPSULE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81964-205-01EA - Each81964-2059a684045-7bcb-4e18-830a-5e456aec097a12022-10-06
81964-205-05EA - Each81964-205cbb85fb2-a1a1-4c06-90c1-f3adb4dbe3b712022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81964-205AMOXICILLIN CAPSULE [USANTIBIOTICS, LLC]5Current NDC, Legacy NDC, 4 package rows20250528_110ba6b1-f175-48a1-8e30-616c02212538.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN110ba6b1-f175-48a1-8e30-616c022125385
308191amoxicillin 500 MG Oral CapsulePSN110ba6b1-f175-48a1-8e30-616c022125385
308182amoxicillin 250 MG Oral CapsuleSCD110ba6b1-f175-48a1-8e30-616c022125385
308191amoxicillin 500 MG Oral CapsuleSCD110ba6b1-f175-48a1-8e30-616c022125385
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY110ba6b1-f175-48a1-8e30-616c022125385
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY110ba6b1-f175-48a1-8e30-616c022125385
308191amoxicillin 500 MG Oral CapsulePSN0a100e76-513c-98d3-e063-6294a90adf474
308191amoxicillin 500 MG Oral CapsuleSCD0a100e76-513c-98d3-e063-6294a90adf474
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY0a100e76-513c-98d3-e063-6294a90adf474
308191amoxicillin 500 MG Oral CapsulePSN4adc198e-39d8-4b3e-bfa4-278aaf4064ae1
308191amoxicillin 500 MG Oral CapsuleSCD4adc198e-39d8-4b3e-bfa4-278aaf4064ae1
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY4adc198e-39d8-4b3e-bfa4-278aaf4064ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81964-205-0181964020501100 CAPSULE in 1 BOTTLE (81964-205-01) 100 capsule2022-09-150000-00-00NoNoCurrent
81964-205-0581964020505500 CAPSULE in 1 BOTTLE (81964-205-05) 500 capsule2022-09-150000-00-00NoNoCurrent
81964-205-1081964020510100 CAPSULE in 1 BOTTLE (81964-205-10) 100 capsule2023-03-01NoNoCurrent
81964-205-608196402056060 CAPSULE in 1 BOTTLE (81964-205-60) 60 capsule2023-03-01NoNoCurrent