FDA.reportPublic FDA data

AMOXICILLIN

Product NDC
61919-424
11-digit product format
619190424
Labeler code
61919
Product ID
61919-424_40433390-cf82-4638-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMOXICILLIN
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA061926
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
250 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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
61919-424-302020-01-31C16284748780-19d75b9cf-de3e-f424-e053-dadaa90a57ceAMOXICILLIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-424-30AMOXICILLIN30 in 1 BOTTLECAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-424-30EA - Each61919-424950b236a-f2a1-40f5-8629-2f8e3c4d0b5012014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [DIRECT RX]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [DIRECT RX]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AMOXICILLIN CAPSULE [DIRECT RX]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [DIRECT RX]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMOXICILLIN CAPSULE [DIRECT RX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [DIRECT RX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMOXICILLIN CAPSULE [DIRECT RX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [DIRECT RX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMOXICILLIN CAPSULE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [DIRECT RX]1
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LAMOXICILLIN CAPSULE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMOXICILLIN CAPSULE [DIRECT RX]1
SHELLACINACTIVE INGREDIENT46N107B71OAMOXICILLIN CAPSULE [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UAMOXICILLIN 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
61919-424AMOXICILLIN CAPSULE [DIRECT RX]2Legacy NDC, 1 package rows20161110_a3b98df9-eddc-441a-84dd-51bc5f8dc6e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSNa3b98df9-eddc-441a-84dd-51bc5f8dc6e42
308182amoxicillin 250 MG Oral CapsuleSCDa3b98df9-eddc-441a-84dd-51bc5f8dc6e42
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYa3b98df9-eddc-441a-84dd-51bc5f8dc6e42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-424-306191904243030 in 1 BOTTLEHistorical