FDA.reportPublic FDA data

Amoxicillin

Product NDC
0093-4161
11-digit product format
000934161
Labeler code
0093
Product ID
0093-4161_31223839-1653-4906-826a-f9d6af179334
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA065119
Marketing category
ANDA
Marketing start
2003-02-26
Substance
AMOXICILLIN
Active strength
400 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
0093-4161-73Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION10037
0093-4161-76Amoxicillin50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION5037
0093-4161-78Amoxicillin75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION7537

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-4161-73ML - Milliliter0093-41618f4e1645-fc99-4eaa-9855-56d8d2ad7cc512012-07-24
0093-4161-76ML - Milliliter0093-4161108a797a-b412-49e7-8fea-8645018b335612012-07-24
0093-4161-78ML - Milliliter0093-416158bdd44b-900d-4552-a955-f1833c7df3f912012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-4161AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE AMOXICILLIN CAPSULE [TEVA PHARMACEUTICALS USA, INC.]34Current NDC, Legacy NDC, 3 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
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN19a5a6d9-8cd1-4013-96ea-e219d6a534ba4
308189amoxicillin 80 MG/ML Oral SuspensionSCD19a5a6d9-8cd1-4013-96ea-e219d6a534ba4
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY19a5a6d9-8cd1-4013-96ea-e219d6a534ba4
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN8dfbaa75-87ba-4a6b-a2db-176441a842af3
308189amoxicillin 80 MG/ML Oral SuspensionSCD8dfbaa75-87ba-4a6b-a2db-176441a842af3
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY8dfbaa75-87ba-4a6b-a2db-176441a842af3
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN4bd3324b-5a65-4cfa-be75-e481895003372
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN45a872b8-07b1-44fe-8b57-cc572d480e2e2
308189amoxicillin 80 MG/ML Oral SuspensionSCD4bd3324b-5a65-4cfa-be75-e481895003372
308189amoxicillin 80 MG/ML Oral SuspensionSCD45a872b8-07b1-44fe-8b57-cc572d480e2e2
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY4bd3324b-5a65-4cfa-be75-e481895003372
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY45a872b8-07b1-44fe-8b57-cc572d480e2e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-4161-7300093416173100 mL in 1 BOTTLE (0093-4161-73) 100 ml2003-02-260000-00-00NoNoCurrent
0093-4161-760009341617650 mL in 1 BOTTLE (0093-4161-76) 50 ml2003-07-010000-00-00NoNoCurrent
0093-4161-780009341617875 mL in 1 BOTTLE (0093-4161-78) 75 ml2003-07-010000-00-00NoNoCurrent