FDA.reportPublic FDA data

AMOXICILLIN

Product NDC
64205-224
11-digit product format
642050224
Labeler code
64205
Product ID
64205-224_a4e7a41f-c95d-4726-9e57-0cf382ce4ddb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ReadyMeds
Application
NDA050754
Marketing category
NDA
Marketing start
1978-07-10
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64205-224-302019-11-27C16284748780-19855e2a2-33e7-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use amoxicillin safely and effectively. See full prescribing information for amoxicillin. Amoxicillin Capsules, Tablets, and Powder for Oral Suspension Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64205-224-30AMOXICILLIN30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET, FILM COATED [READYMEDS]3
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN TABLET, FILM COATED [READYMEDS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN TABLET, FILM COATED [READYMEDS]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN TABLET, FILM COATED [READYMEDS]3
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAMOXICILLIN TABLET, FILM COATED [READYMEDS]3
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4AMOXICILLIN TABLET, FILM COATED [READYMEDS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET, FILM COATED [READYMEDS]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMOXICILLIN TABLET, FILM COATED [READYMEDS]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN TABLET, FILM COATED [READYMEDS]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN TABLET, FILM COATED [READYMEDS]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN TABLET, FILM COATED [READYMEDS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64205-224AMOXICILLIN TABLET, FILM COATED [READYMEDS]3Legacy NDC, 1 package rows20140630_1ce3c575-6de7-4d93-8efc-fa1c75b7ecde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308192amoxicillin 500 MG Oral TabletPSN1ce3c575-6de7-4d93-8efc-fa1c75b7ecde3
308194amoxicillin 875 MG Oral TabletPSN1ce3c575-6de7-4d93-8efc-fa1c75b7ecde3
308192amoxicillin 500 MG Oral TabletSCD1ce3c575-6de7-4d93-8efc-fa1c75b7ecde3
308194amoxicillin 875 MG Oral TabletSCD1ce3c575-6de7-4d93-8efc-fa1c75b7ecde3
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY1ce3c575-6de7-4d93-8efc-fa1c75b7ecde3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64205-224-306420502243030 in 1 BOTTLEHistorical