FDA.reportPublic FDA data

Amoxicillin

Product NDC
0781-5060
11-digit product format
007815060
Labeler code
0781
Product ID
0781-5060_f314ad63-2023-476e-a211-f9cef3be8e2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA065228
Marketing category
ANDA
Marketing start
2005-07-13
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
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-5060-01Amoxicillin100 in 1 BOTTLETABLET, FILM COATED10025
0781-5060-20Amoxicillin20 in 1 BOTTLETABLET, FILM COATED2025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5060-01EA - Each0781-506058425e07-5d42-4c3b-8f75-550ce2efaac812012-07-24
0781-5060-20EA - Each0781-50600fe91c3f-c555-4a33-950a-a64bb4ef016112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
ALCOHOLINACTIVE INGREDIENT3K9958V90MAMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
AMMONIAINACTIVE INGREDIENT5138Q19F1XAMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
ANHYDROUS TRISODIUM CITRATEINACTIVE INGREDIENTRS7A450LGAAMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BAMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TAMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
SHELLACINACTIVE INGREDIENT46N107B71OAMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
TALCINACTIVE INGREDIENT7SEV7J4R1UAMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMAMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
WATERINACTIVE INGREDIENT059QF0KO0RAMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-5060AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]23Legacy NDC, 2 package rows20250116_13bd4214-9b7f-425b-af5f-fc1ddc678230.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSN13bd4214-9b7f-425b-af5f-fc1ddc67823025
313850amoxicillin 200 MG in 5 mL Oral SuspensionPSN13bd4214-9b7f-425b-af5f-fc1ddc67823025
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN13bd4214-9b7f-425b-af5f-fc1ddc67823025
308182amoxicillin 250 MG Oral CapsulePSN13bd4214-9b7f-425b-af5f-fc1ddc67823025
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN13bd4214-9b7f-425b-af5f-fc1ddc67823025
308191amoxicillin 500 MG Oral CapsulePSN13bd4214-9b7f-425b-af5f-fc1ddc67823025
308192amoxicillin 500 MG Oral TabletPSN13bd4214-9b7f-425b-af5f-fc1ddc67823025
308194amoxicillin 875 MG Oral TabletPSN13bd4214-9b7f-425b-af5f-fc1ddc67823025
313797amoxicillin 25 MG/ML Oral SuspensionSCD13bd4214-9b7f-425b-af5f-fc1ddc67823025
308182amoxicillin 250 MG Oral CapsuleSCD13bd4214-9b7f-425b-af5f-fc1ddc67823025
313850amoxicillin 40 MG/ML Oral SuspensionSCD13bd4214-9b7f-425b-af5f-fc1ddc67823025
239191amoxicillin 50 MG/ML Oral SuspensionSCD13bd4214-9b7f-425b-af5f-fc1ddc67823025
308191amoxicillin 500 MG Oral CapsuleSCD13bd4214-9b7f-425b-af5f-fc1ddc67823025
308192amoxicillin 500 MG Oral TabletSCD13bd4214-9b7f-425b-af5f-fc1ddc67823025
308189amoxicillin 80 MG/ML Oral SuspensionSCD13bd4214-9b7f-425b-af5f-fc1ddc67823025
308194amoxicillin 875 MG Oral TabletSCD13bd4214-9b7f-425b-af5f-fc1ddc67823025
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSY13bd4214-9b7f-425b-af5f-fc1ddc67823025
313850amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral SuspensionSY13bd4214-9b7f-425b-af5f-fc1ddc67823025
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY13bd4214-9b7f-425b-af5f-fc1ddc67823025
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY13bd4214-9b7f-425b-af5f-fc1ddc67823025
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY13bd4214-9b7f-425b-af5f-fc1ddc67823025
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY13bd4214-9b7f-425b-af5f-fc1ddc67823025
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY13bd4214-9b7f-425b-af5f-fc1ddc67823025
313797amoxicillin 125 MG per 5 ML Oral SuspensionSY13bd4214-9b7f-425b-af5f-fc1ddc67823025
313850amoxicillin 200 MG per 5 ML Oral SuspensionSY13bd4214-9b7f-425b-af5f-fc1ddc67823025
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY13bd4214-9b7f-425b-af5f-fc1ddc67823025

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-5060-0100781506001100 TABLET, FILM COATED in 1 BOTTLE (0781-5060-01) 2005-07-130000-00-00NoNoCurrent
0781-5060-200078150602020 TABLET, FILM COATED in 1 BOTTLE (0781-5060-20) 2005-07-130000-00-00NoNoCurrent