Amoxicillin

Product NDC
52959-020
11-digit product format
529590020
Labeler code
52959
Product ID
52959-020_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
500 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
52959-020-002020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-022020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-032020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-042020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-052020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-062020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-082020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-122020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-152020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-172020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-182020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-202020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-212020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-222020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-242020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-282020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-302020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-322020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-402020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-422020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-502020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020
52959-020-602020-01-31C16284748780-19d75b9d0-5deb-f424-e053-dadaa90a57ce0011-0020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-020-00Amoxicillin100 in 1 BOTTLECAPSULE1002
52959-020-02Amoxicillin2 in 1 BOTTLECAPSULE22
52959-020-03Amoxicillin3 in 1 BOTTLECAPSULE32
52959-020-04Amoxicillin4 in 1 BOTTLECAPSULE42
52959-020-05Amoxicillin5 in 1 BOTTLECAPSULE52
52959-020-06Amoxicillin6 in 1 BOTTLECAPSULE62
52959-020-08Amoxicillin8 in 1 BOTTLECAPSULE82
52959-020-12Amoxicillin12 in 1 BOTTLECAPSULE122
52959-020-15Amoxicillin15 in 1 BOTTLECAPSULE152
52959-020-17Amoxicillin17 in 1 BOTTLECAPSULE172
52959-020-18Amoxicillin18 in 1 BOTTLECAPSULE182
52959-020-20Amoxicillin20 in 1 BOTTLECAPSULE202
52959-020-21Amoxicillin21 in 1 BOTTLECAPSULE212
52959-020-22Amoxicillin22 in 1 BOTTLECAPSULE222
52959-020-24Amoxicillin24 in 1 BOTTLECAPSULE242
52959-020-28Amoxicillin28 in 1 BOTTLECAPSULE282
52959-020-30Amoxicillin30 in 1 BOTTLECAPSULE302
52959-020-32Amoxicillin32 in 1 BOTTLECAPSULE322
52959-020-40Amoxicillin40 in 1 BOTTLECAPSULE402
52959-020-42Amoxicillin42 in 1 BOTTLECAPSULE422
52959-020-50Amoxicillin50 in 1 BOTTLECAPSULE502
52959-020-60Amoxicillin60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-020-00EA - Each52959-02041f8a6d7-a99d-40eb-a26a-9ef97c6d25e812018-10-11
52959-020-04EA - Each52959-0203abb6ccf-072c-4408-8ba7-6de5d93cee2612012-07-24
52959-020-05EA - Each52959-0208bb47e08-6bd9-461c-af3d-3c4192d7fc5812012-07-24
52959-020-06EA - Each52959-020a38a0f23-eab8-4964-bbaa-80619280d3af12012-07-24
52959-020-18EA - Each52959-0207b896667-de81-4952-be8b-8c2aecac9cc512012-07-24
52959-020-20EA - Each52959-02083c30dea-04da-48cd-bf7f-5bd92c93ad6812012-07-24
52959-020-21EA - Each52959-0207bbf35d1-0ac6-4c93-b370-f29736664d2812012-07-24
52959-020-24EA - Each52959-0205b6cf258-33d1-47bc-8a7f-b4e891690f6612012-07-24
52959-020-28EA - Each52959-0209b2ffdeb-c98c-429a-b975-c3b77cd1a5b212012-07-24
52959-020-30EA - Each52959-0200708b6b1-615b-4d85-82ca-acbdfb368ab312012-07-24
52959-020-40EA - Each52959-020851d02b2-72b3-478d-98a2-d959ee7ffef912012-07-24
52959-020-42EA - Each52959-020a5d70fc1-24b6-4f82-b223-5a85bd43def312012-07-24
52959-020-60EA - Each52959-020a105eef6-cb10-44a7-bf8c-2d9a37fe533312012-07-24

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
52959-020AMOXICILLIN CAPSULE [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 22 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
52959-020-0052959002000100 in 1 BOTTLEHistorical
52959-020-02529590020022 in 1 BOTTLEHistorical
52959-020-03529590020033 in 1 BOTTLEHistorical
52959-020-04529590020044 in 1 BOTTLEHistorical
52959-020-05529590020055 in 1 BOTTLEHistorical
52959-020-06529590020066 in 1 BOTTLEHistorical
52959-020-08529590020088 in 1 BOTTLEHistorical
52959-020-125295900201212 in 1 BOTTLEHistorical
52959-020-155295900201515 in 1 BOTTLEHistorical
52959-020-175295900201717 in 1 BOTTLEHistorical
52959-020-185295900201818 in 1 BOTTLEHistorical
52959-020-205295900202020 in 1 BOTTLEHistorical
52959-020-215295900202121 in 1 BOTTLEHistorical
52959-020-225295900202222 in 1 BOTTLEHistorical
52959-020-245295900202424 in 1 BOTTLEHistorical
52959-020-285295900202828 in 1 BOTTLEHistorical
52959-020-305295900203030 in 1 BOTTLEHistorical
52959-020-325295900203232 in 1 BOTTLEHistorical
52959-020-405295900204040 in 1 BOTTLEHistorical
52959-020-425295900204242 in 1 BOTTLEHistorical
52959-020-505295900205050 in 1 BOTTLEHistorical
52959-020-605295900206060 in 1 BOTTLEHistorical