FDA.reportPublic FDA data

Amoxicillin

Product NDC
50436-7218
11-digit product format
504367218
Labeler code
50436
Product ID
50436-7218_c0a328ab-4b6e-4a05-8cff-162548ea1696
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA065291
Marketing category
ANDA
Marketing start
2007-03-01
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
250 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
50436-7218-12021-01-29C16284748780-1ba0f9c33-2ef5-a910-e053-dadaa90a0b85Amoxicillin Capsules USP, 250 mg and Amoxicillin Capsules USP, 500 mg
50436-7218-32021-01-29C16284748780-1ba0f9c33-2ef5-a910-e053-dadaa90a0b85Amoxicillin Capsules USP, 250 mg and Amoxicillin Capsules USP, 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-7218-1Amoxicillin30 in 1 BOTTLECAPSULE305
50436-7218-3Amoxicillin6 in 1 BOTTLECAPSULE65

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-7218-3EA - Each50436-72187bb82a24-c0bd-48b2-993a-eb69617a259012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [UNIT DOSE SERVICES]3
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [UNIT DOSE SERVICES]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AMOXICILLIN CAPSULE [UNIT DOSE SERVICES]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMOXICILLIN CAPSULE [UNIT DOSE SERVICES]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMOXICILLIN CAPSULE [UNIT DOSE SERVICES]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMOXICILLIN CAPSULE [UNIT DOSE SERVICES]3
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [UNIT DOSE SERVICES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [UNIT DOSE SERVICES]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [UNIT DOSE SERVICES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-7218AMOXICILLIN CAPSULE [UNIT DOSE SERVICES]5Legacy NDC, 2 package rows20190129_0dbb3a86-a601-4d40-ab44-01901660181a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN0dbb3a86-a601-4d40-ab44-01901660181a5
308182amoxicillin 250 MG Oral CapsuleSCD0dbb3a86-a601-4d40-ab44-01901660181a5
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY0dbb3a86-a601-4d40-ab44-01901660181a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-7218-15043672180130 in 1 BOTTLEHistorical
50436-7218-3504367218036 in 1 BOTTLEHistorical