FDA.reportPublic FDA data

Amoxicillin

Product NDC
0093-3109
11-digit product format
000933109
Labeler code
0093
Product ID
0093-3109_31223839-1653-4906-826a-f9d6af179334
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA061926
Marketing category
ANDA
Marketing start
1990-09-30
Substance
AMOXICILLIN
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui239191, 308177, 308182, 308189, 308191, 308192, 308194, 313850, 598025

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-3109-05Amoxicillin500 in 1 BOTTLECAPSULE50037
0093-3109-53Amoxicillin50 in 1 BOTTLECAPSULE5037

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3109-01EA - Each0093-31099fa97d67-0d71-478f-94c3-cf71f2405b8a12024-01-04
0093-3109-05EA - Each0093-31093515fef5-d6f8-4ce3-812d-bded408c992212012-07-24
0093-3109-06EA - Each0093-3109e961aa0d-8d7d-4229-bf57-9d4d4be17f8c12024-01-04
0093-3109-19EA - Each0093-3109ba972ab7-a292-4f03-af52-d72ec365bc0c12012-07-24
0093-3109-53EA - Each0093-3109a6802d40-dea4-4e29-9e74-c59e27eb9c2912012-07-24
0093-3109-93EA - Each0093-31097ea0a40a-9b5e-4fbf-a471-bdfd61854b6312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
SHELLACINACTIVE INGREDIENT46N107B71OAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
TALCINACTIVE INGREDIENT7SEV7J4R1UAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]15
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [MEDVANTX, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AMOXICILLIN CAPSULE [MEDVANTX, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMOXICILLIN CAPSULE [MEDVANTX, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [MEDVANTX, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMOXICILLIN CAPSULE [MEDVANTX, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [MEDVANTX, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3109AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE AMOXICILLIN CAPSULE [TEVA PHARMACEUTICALS USA, INC.]34Current NDC, Legacy NDC, 2 package rows20250502_4c0f348a-a65d-409c-8668-207c82a5e3cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308177amoxicillin 125 MG Chewable TabletPSN4c0f348a-a65d-409c-8668-207c82a5e3cb37
313850amoxicillin 200 MG in 5 mL Oral SuspensionPSN4c0f348a-a65d-409c-8668-207c82a5e3cb37
598025amoxicillin 250 MG Chewable TabletPSN4c0f348a-a65d-409c-8668-207c82a5e3cb37
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN4c0f348a-a65d-409c-8668-207c82a5e3cb37
308182amoxicillin 250 MG Oral CapsulePSN4c0f348a-a65d-409c-8668-207c82a5e3cb37
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN4c0f348a-a65d-409c-8668-207c82a5e3cb37
308191amoxicillin 500 MG Oral CapsulePSN4c0f348a-a65d-409c-8668-207c82a5e3cb37
308192amoxicillin 500 MG Oral TabletPSN4c0f348a-a65d-409c-8668-207c82a5e3cb37
308194amoxicillin 875 MG Oral TabletPSN4c0f348a-a65d-409c-8668-207c82a5e3cb37
308177amoxicillin 125 MG Chewable TabletSCD4c0f348a-a65d-409c-8668-207c82a5e3cb37
598025amoxicillin 250 MG Chewable TabletSCD4c0f348a-a65d-409c-8668-207c82a5e3cb37
308182amoxicillin 250 MG Oral CapsuleSCD4c0f348a-a65d-409c-8668-207c82a5e3cb37
313850amoxicillin 40 MG/ML Oral SuspensionSCD4c0f348a-a65d-409c-8668-207c82a5e3cb37
239191amoxicillin 50 MG/ML Oral SuspensionSCD4c0f348a-a65d-409c-8668-207c82a5e3cb37
308191amoxicillin 500 MG Oral CapsuleSCD4c0f348a-a65d-409c-8668-207c82a5e3cb37
308192amoxicillin 500 MG Oral TabletSCD4c0f348a-a65d-409c-8668-207c82a5e3cb37
308189amoxicillin 80 MG/ML Oral SuspensionSCD4c0f348a-a65d-409c-8668-207c82a5e3cb37
308194amoxicillin 875 MG Oral TabletSCD4c0f348a-a65d-409c-8668-207c82a5e3cb37
313850amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral SuspensionSY4c0f348a-a65d-409c-8668-207c82a5e3cb37
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY4c0f348a-a65d-409c-8668-207c82a5e3cb37
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY4c0f348a-a65d-409c-8668-207c82a5e3cb37
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY4c0f348a-a65d-409c-8668-207c82a5e3cb37
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY4c0f348a-a65d-409c-8668-207c82a5e3cb37
308194amoxicillin (as amoxicillin trihydrate) 875 MG Oral TabletSY4c0f348a-a65d-409c-8668-207c82a5e3cb37
313850amoxicillin 200 MG per 5 ML Oral SuspensionSY4c0f348a-a65d-409c-8668-207c82a5e3cb37
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY4c0f348a-a65d-409c-8668-207c82a5e3cb37
308191amoxicillin 500 MG Oral CapsulePSN60c788d1-6c91-4456-848a-893e649e90be11
308191amoxicillin 500 MG Oral CapsuleSCD60c788d1-6c91-4456-848a-893e649e90be11
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY60c788d1-6c91-4456-848a-893e649e90be11
308191amoxicillin 500 MG Oral CapsulePSNea2481a1-cab6-4c2e-a333-3d687367895d4
308191amoxicillin 500 MG Oral CapsuleSCDea2481a1-cab6-4c2e-a333-3d687367895d4
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYea2481a1-cab6-4c2e-a333-3d687367895d4
308191amoxicillin 500 MG Oral CapsulePSNfadc4d59-d937-4f22-be6b-ce92fbb004822
308191amoxicillin 500 MG Oral CapsuleSCDfadc4d59-d937-4f22-be6b-ce92fbb004822
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYfadc4d59-d937-4f22-be6b-ce92fbb004822
308191amoxicillin 500 MG Oral CapsulePSNbe1d1a44-7ef3-445d-9970-494921de4c9d1
308191amoxicillin 500 MG Oral CapsulePSN3bf1718a-fedc-4834-831e-b3b044f80ee61
308191amoxicillin 500 MG Oral CapsuleSCDbe1d1a44-7ef3-445d-9970-494921de4c9d1
308191amoxicillin 500 MG Oral CapsuleSCD3bf1718a-fedc-4834-831e-b3b044f80ee61
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYbe1d1a44-7ef3-445d-9970-494921de4c9d1
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY3bf1718a-fedc-4834-831e-b3b044f80ee61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-3109-0500093310905500 CAPSULE in 1 BOTTLE (0093-3109-05) 500 capsule1990-09-300000-00-00NoNoCurrent
0093-3109-530009331095350 CAPSULE in 1 BOTTLE (0093-3109-53) 50 capsule1990-09-300000-00-00NoNoCurrent