FDA.reportPublic FDA data

Amoxicillin

Product NDC
0093-3107
11-digit product format
000933107
Labeler code
0093
Product ID
0093-3107_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
250 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
AMOXICILLIN250 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0093-3107-01Amoxicillin100 in 1 BOTTLECAPSULE10037
0093-3107-05Amoxicillin500 in 1 BOTTLECAPSULE50037

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3107-01EA - Each0093-31076ea822c0-56a6-4f83-b717-86bf50d9e15212012-07-24
0093-3107-05EA - Each0093-3107b43ad8f8-514c-4809-ba95-94ff20b028f412012-07-24
0093-3107-19EA - Each0093-3107c8271ba2-2c04-4e56-bbfb-2c486f63eec012012-07-24
0093-3107-93EA - Each0093-3107625290d0-9958-4b8b-b976-bbd625c4515c12012-07-24

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 [REDPHARM DRUG INC.]10
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
SHELLACINACTIVE INGREDIENT46N107B71OAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [REDPHARM DRUG INC.]10
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
SHELLACINACTIVE INGREDIENT46N107B71OAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3107AMOXICILLIN 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
308182amoxicillin 250 MG Oral CapsulePSN80a04b8a-110e-0aea-e053-2a91aa0ad0577
308182amoxicillin 250 MG Oral CapsuleSCD80a04b8a-110e-0aea-e053-2a91aa0ad0577
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY80a04b8a-110e-0aea-e053-2a91aa0ad0577
308182amoxicillin 250 MG Oral CapsulePSN8c3ba9cf-9a28-3965-e053-2a95a90a38ce2
308182amoxicillin 250 MG Oral CapsuleSCD8c3ba9cf-9a28-3965-e053-2a95a90a38ce2
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY8c3ba9cf-9a28-3965-e053-2a95a90a38ce2
308182amoxicillin 250 MG Oral CapsulePSN3d0025b4-b7bb-69db-e063-6294a90a0e701
308182amoxicillin 250 MG Oral CapsuleSCD3d0025b4-b7bb-69db-e063-6294a90a0e701
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSY3d0025b4-b7bb-69db-e063-6294a90a0e701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-3107-0100093310701100 CAPSULE in 1 BOTTLE (0093-3107-01) 100 capsule1990-09-300000-00-00NoNoCurrent
0093-3107-0500093310705500 CAPSULE in 1 BOTTLE (0093-3107-05) 500 capsule1990-09-300000-00-00NoNoCurrent