FDA.reportPublic FDA data

Amoxicillin

Product NDC
52959-011
11-digit product format
529590011
Labeler code
52959
Product ID
52959-011_7539b242-a0fb-12c2-e053-2a91aa0a3780
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA065271
Marketing category
ANDA
Marketing start
2005-09-11
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
2019-12-31
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
52959-011-152020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-011-202020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-011-212020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-011-242020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-011-302020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-011-402020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-011-602020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-011-15Amoxicillin15 in 1 BOTTLECAPSULE152
52959-011-20Amoxicillin20 in 1 BOTTLECAPSULE202
52959-011-21Amoxicillin21 in 1 BOTTLECAPSULE212
52959-011-24Amoxicillin24 in 1 BOTTLECAPSULE242
52959-011-30Amoxicillin30 in 1 BOTTLECAPSULE302
52959-011-40Amoxicillin40 in 1 BOTTLECAPSULE402
52959-011-60Amoxicillin60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-011-20EA - Each52959-01169992c4d-63bf-4cd1-b2c1-45c3cb04ce5412012-07-24
52959-011-21EA - Each52959-011a087f6e4-e475-43c7-943e-295b34629c9312012-07-24
52959-011-24EA - Each52959-0116189c51c-0807-4764-a86e-4f75a570fcf112012-07-24
52959-011-30EA - Each52959-01174278e7b-200a-4a10-be0e-da3665f0a9d412012-07-24
52959-011-40EA - Each52959-011adcc58ad-4d0a-41bc-8831-f3229dc43b2412012-07-24
52959-011-60EA - Each52959-0117eec27e9-2611-474d-bfbe-ea094a0ea06412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [H.J. HARKINS COMPANY, INC.]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [H.J. HARKINS COMPANY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE [H.J. HARKINS COMPANY, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [H.J. HARKINS COMPANY, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [H.J. HARKINS COMPANY, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [H.J. HARKINS COMPANY, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [H.J. HARKINS COMPANY, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [H.J. HARKINS COMPANY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-011AMOXICILLIN CAPSULE [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 7 package rows20180911_520b05ef-420e-47d5-9491-63a7ba9e5423.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308182amoxicillin 250 MG Oral CapsulePSN520b05ef-420e-47d5-9491-63a7ba9e54232
308191amoxicillin 500 MG Oral CapsulePSN520b05ef-420e-47d5-9491-63a7ba9e54232
308182amoxicillin 250 MG Oral CapsuleSCD520b05ef-420e-47d5-9491-63a7ba9e54232
308191amoxicillin 500 MG Oral CapsuleSCD520b05ef-420e-47d5-9491-63a7ba9e54232
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY520b05ef-420e-47d5-9491-63a7ba9e54232
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY520b05ef-420e-47d5-9491-63a7ba9e54232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-011-155295900111515 in 1 BOTTLEHistorical
52959-011-205295900112020 in 1 BOTTLEHistorical
52959-011-215295900112121 in 1 BOTTLEHistorical
52959-011-245295900112424 in 1 BOTTLEHistorical
52959-011-305295900113030 in 1 BOTTLEHistorical
52959-011-405295900114040 in 1 BOTTLEHistorical
52959-011-605295900116060 in 1 BOTTLEHistorical