FDA.reportPublic FDA data

Amoxicillin

Product NDC
0143-9939
11-digit product format
001439939
Labeler code
0143
Product ID
0143-9939_3dff1b4d-37d9-4573-b2c1-039b4686283f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065291
Marketing category
ANDA
Marketing start
2007-03-01
Substance
AMOXICILLIN
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308191

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
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9939-05Amoxicillin500 in 1 BOTTLE, PLASTICCAPSULE50022
0143-9939-28Amoxicillin480 in 1 BOTTLE, PLASTICCAPSULE48022
0143-9938-01Amoxicillin100 in 1 BOTTLE, PLASTICCAPSULE1001
0143-9939-05Amoxicillin500 in 1 BOTTLE, PLASTICCAPSULE5001
0143-9939-20Amoxicillin20 in 1 BOTTLE, PLASTICCAPSULE201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9939-01EA - Each0143-993951d523fc-0290-49a4-b636-3b4aa604f33e12012-07-24
0143-9939-05EA - Each0143-9939edc2c7ee-048e-4c7a-a401-a5b9ea2efd8512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP]7
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AMOXICILLIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMOXICILLIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMOXICILLIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMOXICILLIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP]7
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [WEST-WARD PHARMACEUTICAL CORP]7
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
AMOXICILLINACTIVE MOIETY804826J2HUAMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
AmoxicillinACTIVE INGREDIENT804826J2HUAMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
AmoxicillinACTIVE MOIETY804826J2HUAMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]1
AMOXICILLINACTIVE MOIETY804826J2HUAMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
Croscarmellose sodiumINACTIVE INGREDIENTAMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
GelatinINACTIVE INGREDIENT2G86QN327LAMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]1
GELATININACTIVE INGREDIENT2G86QN327LAMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30AMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN CAPSULE [ALTURA PHARMACEUTICALS, INC.]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]1
Yellow Iron OxideINACTIVE INGREDIENTAMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9939AMOXICILLIN CAPSULE [HIKMA PHARMACEUTICALS USA INC.]20Current NDC, Legacy NDC, 2 package rows20240821_4fb7837e-964c-4d38-a3a5-b384b1bd6e08.zip
0143-9939AMOXICILLIN (AMOXICILLIN) CAPSULE [WEST-WARD PHARMACEUTICAL CORP.]1Current NDC, Legacy NDC, 3 package rows20080505_de8990a6-f3b6-478f-acbe-eda961b6da4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSNb988349d-2198-4dbb-a231-9ba37262ce2838
308191amoxicillin 500 MG Oral CapsuleSCDb988349d-2198-4dbb-a231-9ba37262ce2838
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYb988349d-2198-4dbb-a231-9ba37262ce2838
308191amoxicillin 500 MG Oral CapsulePSN521f7a05-4e6d-447f-b38e-00c4d623703b29
308191amoxicillin 500 MG Oral CapsuleSCD521f7a05-4e6d-447f-b38e-00c4d623703b29
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY521f7a05-4e6d-447f-b38e-00c4d623703b29
308191amoxicillin 500 MG Oral CapsulePSN364f969d-3037-4dff-b04b-304bca27442e27
308191amoxicillin 500 MG Oral CapsuleSCD364f969d-3037-4dff-b04b-304bca27442e27
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY364f969d-3037-4dff-b04b-304bca27442e27
308191amoxicillin 500 MG Oral CapsulePSN96057ce7-9516-4239-9974-5e9691b44c9b26
308191amoxicillin 500 MG Oral CapsuleSCD96057ce7-9516-4239-9974-5e9691b44c9b26
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY96057ce7-9516-4239-9974-5e9691b44c9b26
308191amoxicillin 500 MG Oral CapsulePSN4fb7837e-964c-4d38-a3a5-b384b1bd6e0822
308191amoxicillin 500 MG Oral CapsuleSCD4fb7837e-964c-4d38-a3a5-b384b1bd6e0822
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY4fb7837e-964c-4d38-a3a5-b384b1bd6e0822
308191amoxicillin 500 MG Oral CapsulePSN039d2677-b04f-436c-e063-6294a90ac51921
308191amoxicillin 500 MG Oral CapsuleSCD039d2677-b04f-436c-e063-6294a90ac51921
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY039d2677-b04f-436c-e063-6294a90ac51921
308191amoxicillin 500 MG Oral CapsulePSN18a4f555-a537-4c40-9bb2-dc3bd782fa2720
308191amoxicillin 500 MG Oral CapsuleSCD18a4f555-a537-4c40-9bb2-dc3bd782fa2720
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY18a4f555-a537-4c40-9bb2-dc3bd782fa2720
308191amoxicillin 500 MG Oral CapsulePSNfd071263-b750-4831-9fc5-de112a5f685b16
308191amoxicillin 500 MG Oral CapsuleSCDfd071263-b750-4831-9fc5-de112a5f685b16
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYfd071263-b750-4831-9fc5-de112a5f685b16
308191amoxicillin 500 MG Oral CapsulePSNa61e4152-48e9-6b40-e053-2995a90a6aad5
308191amoxicillin 500 MG Oral CapsuleSCDa61e4152-48e9-6b40-e053-2995a90a6aad5
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYa61e4152-48e9-6b40-e053-2995a90a6aad5
308191amoxicillin 500 MG Oral CapsulePSN8b256346-944f-54b5-e053-2995a90ae2592
308191amoxicillin 500 MG Oral CapsulePSN3afc3097-a757-49a0-aaec-85ac267aabb12
308191amoxicillin 500 MG Oral CapsulePSNb6ea2f81-aee6-4c88-b681-50eb28e80a862
308191amoxicillin 500 MG Oral CapsuleSCD3afc3097-a757-49a0-aaec-85ac267aabb12
308191amoxicillin 500 MG Oral CapsuleSCDb6ea2f81-aee6-4c88-b681-50eb28e80a862
308191amoxicillin 500 MG Oral CapsuleSCD8b256346-944f-54b5-e053-2995a90ae2592
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYb6ea2f81-aee6-4c88-b681-50eb28e80a862
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY8b256346-944f-54b5-e053-2995a90ae2592
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY3afc3097-a757-49a0-aaec-85ac267aabb12
308182amoxicillin 250 MG Oral CapsulePSNf0b9c446-37c1-4e0a-9e39-eb7fabaf7c7b1
308191amoxicillin 500 MG Oral CapsulePSNf0b9c446-37c1-4e0a-9e39-eb7fabaf7c7b1
308182amoxicillin 250 MG Oral CapsuleSCDf0b9c446-37c1-4e0a-9e39-eb7fabaf7c7b1
308191amoxicillin 500 MG Oral CapsuleSCDf0b9c446-37c1-4e0a-9e39-eb7fabaf7c7b1
308182amoxicillin (as amoxicillin trihydrate) 250 MG Oral CapsuleSYf0b9c446-37c1-4e0a-9e39-eb7fabaf7c7b1
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSYf0b9c446-37c1-4e0a-9e39-eb7fabaf7c7b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9938-0100143993801100 in 1 BOTTLE, PLASTICHistorical
0143-9939-0100143993901100 CAPSULE in 1 BOTTLE, PLASTIC (0143-9939-01) 100 capsule2007-03-010000-00-00NoNoCurrent
0143-9939-0500143993905500 CAPSULE in 1 BOTTLE, PLASTIC (0143-9939-05) 500 capsule2007-03-010000-00-00NoNoCurrent
0143-9939-200014399392020 CAPSULE in 1 BOTTLE, PLASTIC (0143-9939-20) 20 capsule2007-03-010000-00-00NoNoCurrent
0143-9939-2800143993928480 CAPSULE in 1 BOTTLE, PLASTIC (0143-9939-28) 480 capsule2026-04-22NoNoHistorical