FDA.reportPublic FDA data

Amoxicillin

Product NDC
0143-9888
11-digit product format
001439888
Labeler code
0143
Product ID
0143-9888_c2fa2c99-c735-4834-a8a5-04a30da8a002
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065322
Marketing category
ANDA
Marketing start
2006-06-19
Substance
AMOXICILLIN
Active strength
125 mg/5mL
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
AMOXICILLIN125 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui239191, 313797

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
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9888-01Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1003
0143-9888-15Amoxicillin150 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1503
0143-9888-80Amoxicillin80 mL in 1 BOTTLEPOWDER, FOR SUSPENSION803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9888-01ML - Milliliter0143-9888d7aa5e75-1054-4375-b4aa-dea051dee8e412012-07-24
0143-9888-15ML - Milliliter0143-9888bc3b3dd3-e9c7-401e-ab88-9be849f615f212012-07-24
0143-9888-80ML - Milliliter0143-9888b1929207-b15c-4127-8cf3-ad74bf14ab6a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]6
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]6
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9888AMOXICILLIN POWDER, FOR SUSPENSION [HIKMA PHARMACEUTICALS USA INC.]3Current NDC, Legacy NDC, 3 package rows20240712_077f4a65-3cfb-4cb1-99f2-e27ffc5939c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSN5b2a2e62-6fd2-4ab1-b936-8702e68233fa16
313797amoxicillin 25 MG/ML Oral SuspensionSCD5b2a2e62-6fd2-4ab1-b936-8702e68233fa16
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSY5b2a2e62-6fd2-4ab1-b936-8702e68233fa16
313797amoxicillin 125 MG per 5 ML Oral SuspensionSY5b2a2e62-6fd2-4ab1-b936-8702e68233fa16
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSN60c7ae87-9631-4b29-9ca4-82fb3bafcab811
313797amoxicillin 25 MG/ML Oral SuspensionSCD60c7ae87-9631-4b29-9ca4-82fb3bafcab811
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSY60c7ae87-9631-4b29-9ca4-82fb3bafcab811
313797amoxicillin 125 MG per 5 ML Oral SuspensionSY60c7ae87-9631-4b29-9ca4-82fb3bafcab811
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSNcb78a002-8505-4e38-9cc1-4a8bd59c29026
313797amoxicillin 25 MG/ML Oral SuspensionSCDcb78a002-8505-4e38-9cc1-4a8bd59c29026
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSYcb78a002-8505-4e38-9cc1-4a8bd59c29026
313797amoxicillin 125 MG per 5 ML Oral SuspensionSYcb78a002-8505-4e38-9cc1-4a8bd59c29026
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSN6a9cfa97-3715-4b75-a1e3-932a34a942d45
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSN5c60cb1c-3baf-3af2-e053-2a91aa0ae2085
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSN5f8b3c58-ed9f-84a2-e053-2a91aa0ac8cf5
313797amoxicillin 25 MG/ML Oral SuspensionSCD6a9cfa97-3715-4b75-a1e3-932a34a942d45
313797amoxicillin 25 MG/ML Oral SuspensionSCD5c60cb1c-3baf-3af2-e053-2a91aa0ae2085
313797amoxicillin 25 MG/ML Oral SuspensionSCD5f8b3c58-ed9f-84a2-e053-2a91aa0ac8cf5
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSY6a9cfa97-3715-4b75-a1e3-932a34a942d45
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSY5f8b3c58-ed9f-84a2-e053-2a91aa0ac8cf5
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSY5c60cb1c-3baf-3af2-e053-2a91aa0ae2085
313797amoxicillin 125 MG per 5 ML Oral SuspensionSY5f8b3c58-ed9f-84a2-e053-2a91aa0ac8cf5
313797amoxicillin 125 MG per 5 ML Oral SuspensionSY5c60cb1c-3baf-3af2-e053-2a91aa0ae2085
313797amoxicillin 125 MG per 5 ML Oral SuspensionSY6a9cfa97-3715-4b75-a1e3-932a34a942d45
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSN077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
313797amoxicillin 25 MG/ML Oral SuspensionSCD077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
239191amoxicillin 50 MG/ML Oral SuspensionSCD077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSY077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
313797amoxicillin 125 MG per 5 ML Oral SuspensionSY077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSN9cad7ff5-5151-47d9-bc66-2ded25deefc21
313797amoxicillin 25 MG/ML Oral SuspensionSCD9cad7ff5-5151-47d9-bc66-2ded25deefc21
313797amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral SuspensionSY9cad7ff5-5151-47d9-bc66-2ded25deefc21
313797amoxicillin 125 MG per 5 ML Oral SuspensionSY9cad7ff5-5151-47d9-bc66-2ded25deefc21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9888-0100143988801100 mL in 1 BOTTLE (0143-9888-01) 100 ml2006-06-190000-00-00NoNoCurrent
0143-9888-1500143988815150 mL in 1 BOTTLE (0143-9888-15) 150 ml2006-06-190000-00-00NoNoCurrent
0143-9888-800014398888080 mL in 1 BOTTLE (0143-9888-80) 80 ml2006-06-190000-00-00NoNoCurrent