AMOXICILLIN

Product NDC
61919-016
11-digit product format
619190016
Labeler code
61919
Product ID
61919-016_35bb9a75-990e-6515-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMOXICILLIN
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA062884
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
61919-016-20AMOXICILLIN20 in 1 BOTTLECAPSULE205
61919-016-30AMOXICILLIN30 in 1 BOTTLECAPSULE305
61919-016-60AMOXICILLIN60 in 1 BOTTLECAPSULE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-016-20EA - Each61919-0162e02c9e3-3e19-4194-b6bd-68765b9db64412015-03-03
61919-016-30EA - Each61919-016f2007a4c-c687-40df-8a33-500a56eee90d12015-03-03
61919-016-60EA - Each61919-01682be5a56-31bd-4050-8bb9-71ca4e9d4c4712015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [DIRECT RX]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [DIRECT RX]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LAMOXICILLIN CAPSULE [DIRECT RX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [DIRECT RX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [DIRECT RX]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AMOXICILLIN CAPSULE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-016AMOXICILLIN CAPSULE [DIRECT RX]5Legacy NDC, 3 package rows20161018_8fbf98c5-0e34-46ab-bcef-b7c96b29200c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN8fbf98c5-0e34-46ab-bcef-b7c96b29200c5
308191amoxicillin 500 MG Oral CapsuleSCD8fbf98c5-0e34-46ab-bcef-b7c96b29200c5
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY8fbf98c5-0e34-46ab-bcef-b7c96b29200c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-016-206191900162020 in 1 BOTTLEHistorical
61919-016-306191900163030 in 1 BOTTLEHistorical
61919-016-606191900166060 in 1 BOTTLEHistorical