FDA.reportPublic FDA data

Amoxicillin

Product NDC
0143-9887
11-digit product format
001439887
Labeler code
0143
Product ID
0143-9887_606474e1-adba-4ffa-83d5-6565fc12c892
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065325
Marketing category
ANDA
Marketing start
2006-06-19
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN400 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308189, 313850

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
0143-9887-01Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION10024
0143-9887-50Amoxicillin50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION5024
0143-9887-75Amoxicillin75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION7524

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9887-01ML - Milliliter0143-988717d82ecd-07bc-46cb-bc3a-b6938b6beab512012-07-24
0143-9887-50ML - Milliliter0143-98876933d03b-b3b7-4edd-850c-93a61c685cbb12012-07-24
0143-9887-75ML - Milliliter0143-98870afcfed4-8142-4198-82fa-4b1f73141e0d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]16
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]16
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]16
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]16
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]16
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]16
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]16
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9887AMOXICILLIN POWDER, FOR SUSPENSION [HIKMA PHARMACEUTICALS USA INC.]24Current NDC, Legacy NDC, 3 package rows20240704_d46f1091-33dc-4f8f-9c34-75dcfedb4b4c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313850amoxicillin 200 MG in 5 mL Oral SuspensionPSNd46f1091-33dc-4f8f-9c34-75dcfedb4b4c24
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSNd46f1091-33dc-4f8f-9c34-75dcfedb4b4c24
313850amoxicillin 40 MG/ML Oral SuspensionSCDd46f1091-33dc-4f8f-9c34-75dcfedb4b4c24
308189amoxicillin 80 MG/ML Oral SuspensionSCDd46f1091-33dc-4f8f-9c34-75dcfedb4b4c24
313850amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral SuspensionSYd46f1091-33dc-4f8f-9c34-75dcfedb4b4c24
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSYd46f1091-33dc-4f8f-9c34-75dcfedb4b4c24
313850amoxicillin 200 MG per 5 ML Oral SuspensionSYd46f1091-33dc-4f8f-9c34-75dcfedb4b4c24
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSNcef5b1ae-8454-4e7a-8830-dd5d601c1d2117
308189amoxicillin 80 MG/ML Oral SuspensionSCDcef5b1ae-8454-4e7a-8830-dd5d601c1d2117
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSYcef5b1ae-8454-4e7a-8830-dd5d601c1d2117
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN156ef8e9-b6e4-4512-865f-7139c90c8f9b16
308189amoxicillin 80 MG/ML Oral SuspensionSCD156ef8e9-b6e4-4512-865f-7139c90c8f9b16
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY156ef8e9-b6e4-4512-865f-7139c90c8f9b16
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN77265bcd-c05d-443a-84c4-6e5ac75ee42c9
308189amoxicillin 80 MG/ML Oral SuspensionSCD77265bcd-c05d-443a-84c4-6e5ac75ee42c9
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY77265bcd-c05d-443a-84c4-6e5ac75ee42c9
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN59a546ed-84b7-a54a-e053-2991aa0a3a0d5
308189amoxicillin 80 MG/ML Oral SuspensionSCD59a546ed-84b7-a54a-e053-2991aa0a3a0d5
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY59a546ed-84b7-a54a-e053-2991aa0a3a0d5
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN4a57711c-befe-488c-9cbc-d92e89c425ed4
308189amoxicillin 80 MG/ML Oral SuspensionSCD4a57711c-befe-488c-9cbc-d92e89c425ed4
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY4a57711c-befe-488c-9cbc-d92e89c425ed4
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN8398f2c9-37ca-9b59-e053-2991aa0a2c113
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSNc0e333d9-164d-4196-b5f5-929993d1c3c23
308189amoxicillin 80 MG/ML Oral SuspensionSCD8398f2c9-37ca-9b59-e053-2991aa0a2c113
308189amoxicillin 80 MG/ML Oral SuspensionSCDc0e333d9-164d-4196-b5f5-929993d1c3c23
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSYc0e333d9-164d-4196-b5f5-929993d1c3c23
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY8398f2c9-37ca-9b59-e053-2991aa0a2c113
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN756545f1-77af-49a0-a697-4cced31711d42
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSNd72d2646-1d2f-4f0e-a56d-7891e13891b52
308189amoxicillin 80 MG/ML Oral SuspensionSCD756545f1-77af-49a0-a697-4cced31711d42
308189amoxicillin 80 MG/ML Oral SuspensionSCDd72d2646-1d2f-4f0e-a56d-7891e13891b52
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY756545f1-77af-49a0-a697-4cced31711d42
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSYd72d2646-1d2f-4f0e-a56d-7891e13891b52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9887-0100143988701100 mL in 1 BOTTLE (0143-9887-01) 100 ml2006-06-190000-00-00NoNoCurrent
0143-9887-500014398875050 mL in 1 BOTTLE (0143-9887-50) 50 ml2006-06-190000-00-00NoNoCurrent
0143-9887-750014398877575 mL in 1 BOTTLE (0143-9887-75) 75 ml2006-06-190000-00-00NoNoCurrent