FDA.reportPublic FDA data

Amoxicillin

Product NDC
0143-9889
11-digit product format
001439889
Labeler code
0143
Product ID
0143-9889_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
250 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
AMOXICILLIN250 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
0143-9889-01Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1003
0143-9889-15Amoxicillin150 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1503
0143-9889-80Amoxicillin80 mL in 1 BOTTLEPOWDER, FOR SUSPENSION803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9889-01ML - Milliliter0143-98894a991313-40d8-494c-9f55-e410b843b4ae12012-07-24
0143-9889-15ML - Milliliter0143-98892dc5407e-6d9f-4e5a-be42-2dc4ea9847f212013-05-02
0143-9889-80ML - Milliliter0143-9889a8c22faa-3084-49d6-a5d9-b9912fb43ee312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]4
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]4
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]4
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]4
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]2
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]1
AMOXICILLINACTIVE MOIETY804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9889AMOXICILLIN 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
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN6c7bccff-00bf-46b0-a9ee-eb27d38d737716
239191amoxicillin 50 MG/ML Oral SuspensionSCD6c7bccff-00bf-46b0-a9ee-eb27d38d737716
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY6c7bccff-00bf-46b0-a9ee-eb27d38d737716
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY6c7bccff-00bf-46b0-a9ee-eb27d38d737716
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSNca2886d0-7be7-4d41-bad5-df3ad44e0e7e13
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN8bce45db-dea7-4090-9d64-8b11b08d963e13
239191amoxicillin 50 MG/ML Oral SuspensionSCDca2886d0-7be7-4d41-bad5-df3ad44e0e7e13
239191amoxicillin 50 MG/ML Oral SuspensionSCD8bce45db-dea7-4090-9d64-8b11b08d963e13
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSYca2886d0-7be7-4d41-bad5-df3ad44e0e7e13
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY8bce45db-dea7-4090-9d64-8b11b08d963e13
239191amoxicillin 250 MG per 5 ML Oral SuspensionSYca2886d0-7be7-4d41-bad5-df3ad44e0e7e13
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY8bce45db-dea7-4090-9d64-8b11b08d963e13
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN0b5acc3f-c474-4b16-9d66-8048abb3b22d9
239191amoxicillin 50 MG/ML Oral SuspensionSCD0b5acc3f-c474-4b16-9d66-8048abb3b22d9
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY0b5acc3f-c474-4b16-9d66-8048abb3b22d9
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY0b5acc3f-c474-4b16-9d66-8048abb3b22d9
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN54c1d2a4-fe96-6efb-e054-00144ff88e886
239191amoxicillin 50 MG/ML Oral SuspensionSCD54c1d2a4-fe96-6efb-e054-00144ff88e886
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY54c1d2a4-fe96-6efb-e054-00144ff88e886
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY54c1d2a4-fe96-6efb-e054-00144ff88e886
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN9cac2bf2-fb48-4e83-b953-61c4d55f7e194
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN4b359b26-8682-46fa-90a1-6270502ba9904
239191amoxicillin 50 MG/ML Oral SuspensionSCD9cac2bf2-fb48-4e83-b953-61c4d55f7e194
239191amoxicillin 50 MG/ML Oral SuspensionSCD4b359b26-8682-46fa-90a1-6270502ba9904
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY4b359b26-8682-46fa-90a1-6270502ba9904
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY9cac2bf2-fb48-4e83-b953-61c4d55f7e194
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY4b359b26-8682-46fa-90a1-6270502ba9904
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY9cac2bf2-fb48-4e83-b953-61c4d55f7e194
313797amoxicillin 125 MG in 5 mL Oral SuspensionPSN077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN0ce05282-995c-461e-b807-facb1fcbb4053
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN8b28d3ac-0d6a-456b-a428-9ec6fe061d953
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSNbd46de4c-4571-ba9a-e053-2a95a90a792d3
313797amoxicillin 25 MG/ML Oral SuspensionSCD077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
239191amoxicillin 50 MG/ML Oral SuspensionSCD8b28d3ac-0d6a-456b-a428-9ec6fe061d953
239191amoxicillin 50 MG/ML Oral SuspensionSCD0ce05282-995c-461e-b807-facb1fcbb4053
239191amoxicillin 50 MG/ML Oral SuspensionSCDbd46de4c-4571-ba9a-e053-2a95a90a792d3
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 SuspensionSY0ce05282-995c-461e-b807-facb1fcbb4053
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY8b28d3ac-0d6a-456b-a428-9ec6fe061d953
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSYbd46de4c-4571-ba9a-e053-2a95a90a792d3
313797amoxicillin 125 MG per 5 ML Oral SuspensionSY077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY0ce05282-995c-461e-b807-facb1fcbb4053
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY8b28d3ac-0d6a-456b-a428-9ec6fe061d953
239191amoxicillin 250 MG per 5 ML Oral SuspensionSYbd46de4c-4571-ba9a-e053-2a95a90a792d3
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY077f4a65-3cfb-4cb1-99f2-e27ffc5939c03
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN754641ad-5bca-45d6-a6ff-c06d4e3db47a2
239191amoxicillin 50 MG/ML Oral SuspensionSCD754641ad-5bca-45d6-a6ff-c06d4e3db47a2
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY754641ad-5bca-45d6-a6ff-c06d4e3db47a2
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY754641ad-5bca-45d6-a6ff-c06d4e3db47a2
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN2177c68d-2884-ce70-e063-6294a90aa2671
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN3e1df272-caf6-4247-8ccf-4e37bfe67e0a1
239191amoxicillin 50 MG/ML Oral SuspensionSCD2177c68d-2884-ce70-e063-6294a90aa2671
239191amoxicillin 50 MG/ML Oral SuspensionSCD3e1df272-caf6-4247-8ccf-4e37bfe67e0a1
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY2177c68d-2884-ce70-e063-6294a90aa2671
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY3e1df272-caf6-4247-8ccf-4e37bfe67e0a1
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY2177c68d-2884-ce70-e063-6294a90aa2671
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY3e1df272-caf6-4247-8ccf-4e37bfe67e0a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9889-0100143988901100 mL in 1 BOTTLE (0143-9889-01) 100 ml2006-06-190000-00-00NoNoCurrent
0143-9889-1500143988915150 mL in 1 BOTTLE (0143-9889-15) 150 ml2006-06-190000-00-00NoNoCurrent
0143-9889-800014398898080 mL in 1 BOTTLE (0143-9889-80) 80 ml2006-06-190000-00-00NoNoCurrent