Amoxicillin

Product NDC
0143-9938
11-digit product format
001439938
Labeler code
0143
Product ID
0143-9938_115a6df6-443c-4d92-8d79-2e29e38fbc70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
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
2022-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9938-01Amoxicillin100 in 1 BOTTLE, PLASTICCAPSULE1001
0143-9938-01Amoxicillin100 in 1 BOTTLE, PLASTICCAPSULE1001
0143-9938-05Amoxicillin500 in 1 BOTTLE, PLASTICCAPSULE5001
0143-9938-30Amoxicillin30 in 1 BOTTLE, PLASTICCAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9938-01EA - Each0143-99384078d0a4-d60e-4c8f-becc-023de162adbc12012-07-24
0143-9938-05EA - Each0143-99380a4ec8b4-99be-44e1-b457-f86f3b7ace1012012-07-24

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
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
AmoxicillinACTIVE INGREDIENT804826J2HUAMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]1
AmoxicillinACTIVE MOIETY804826J2HUAMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]1
AMOXICILLINACTIVE MOIETY804826J2HUAMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
Croscarmellose sodiumINACTIVE INGREDIENTAMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
GelatinINACTIVE INGREDIENT2G86QN327LAMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]1
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30AMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]1
Yellow Iron OxideINACTIVE INGREDIENTAMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9938AMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]1Legacy NDC, 3 package rows20080505_de8990a6-f3b6-478f-acbe-eda961b6da4b.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
308182amoxicillin 250 MG Oral CapsulePSNf0b9c446-37c1-4e0a-9e39-eb7fabaf7c7b1
308191amoxicillin 500 MG Oral CapsulePSNf0b9c446-37c1-4e0a-9e39-eb7fabaf7c7b1
308182amoxicillin 250 MG Oral CapsuleSCDf0b9c446-37c1-4e0a-9e39-eb7fabaf7c7b1
308191amoxicillin 500 MG Oral CapsuleSCDf0b9c446-37c1-4e0a-9e39-eb7fabaf7c7b1
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYf0b9c446-37c1-4e0a-9e39-eb7fabaf7c7b1
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYf0b9c446-37c1-4e0a-9e39-eb7fabaf7c7b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9938-0100143993801100 CAPSULE in 1 BOTTLE, PLASTIC (0143-9938-01) 100 capsule2007-03-010000-00-00NoNoCurrent
0143-9938-0500143993805500 CAPSULE in 1 BOTTLE, PLASTIC (0143-9938-05) 500 capsule2007-03-010000-00-00NoNoCurrent
0143-9938-300014399383030 CAPSULE in 1 BOTTLE, PLASTIC (0143-9938-30) 30 capsule2007-03-010000-00-00NoNoCurrent