FDA.reportPublic FDA data

Amoxicillin

Product NDC
0143-9951
11-digit product format
001439951
Labeler code
0143
Product ID
0143-9951_e6d811af-6e3d-443c-819e-94283bd57f9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
West-Ward Pharmaceutical Corp
Application
ANDA065255
Marketing category
ANDA
Marketing start
2006-03-29
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
875 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9951-01EA - Each0143-9951177ad1ad-a098-4ca2-852c-394b5b8ef2ea12012-07-24
0143-9951-20EA - Each0143-99519ec1a8c5-fd7f-4b69-8534-9fe9a07f28b612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]5
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UAMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]5
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
POLYETHYLENE GLYCOLsINACTIVE INGREDIENT3WJQ0SDW1AAMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UAMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN TABLET, COATED [DISPENSING SOLUTIONS, INC.]3
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AAMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UAMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN TABLET, COATED [REDPHARM DRUG INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308194amoxicillin 875 MG Oral TabletPSN0817cc63-8724-4e9c-9531-fab4406597e410
308194amoxicillin 875 MG Oral TabletSCD0817cc63-8724-4e9c-9531-fab4406597e410
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY0817cc63-8724-4e9c-9531-fab4406597e410
308194amoxicillin 875 MG Oral TabletPSN8b05414e-745b-40e8-b3d0-07c4789e19ea8
308194amoxicillin 875 MG Oral TabletSCD8b05414e-745b-40e8-b3d0-07c4789e19ea8
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY8b05414e-745b-40e8-b3d0-07c4789e19ea8
308194amoxicillin 875 MG Oral TabletPSN0fc675ec-e756-274e-e054-00144ff88e885
308194amoxicillin 875 MG Oral TabletSCD0fc675ec-e756-274e-e054-00144ff88e885
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY0fc675ec-e756-274e-e054-00144ff88e885
308194amoxicillin 875 MG Oral TabletPSN74e8883b-1334-4132-a31a-adb1cd05f80b3
308194amoxicillin 875 MG Oral TabletSCD74e8883b-1334-4132-a31a-adb1cd05f80b3
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY74e8883b-1334-4132-a31a-adb1cd05f80b3
308194amoxicillin 875 MG Oral TabletPSN01484f7c-24c9-4c0a-8ae5-c483cb7e6aaa2
308194amoxicillin 875 MG Oral TabletSCD01484f7c-24c9-4c0a-8ae5-c483cb7e6aaa2
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY01484f7c-24c9-4c0a-8ae5-c483cb7e6aaa2