FDA.reportPublic FDA data

Amoxicillin

Product NDC
65862-070
11-digit product format
658620070
Labeler code
65862
Product ID
65862-070_3e3ca279-1838-4348-a01c-df10a8bcb8b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA065334
Marketing category
ANDA
Marketing start
2006-12-28
Substance
AMOXICILLIN
Active strength
200 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
AMOXICILLIN200 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
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
65862-070-01Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION10015
65862-070-50Amoxicillin50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION5015
65862-070-75Amoxicillin75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION7515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-070-01ML - Milliliter65862-0704a24e774-8a98-4954-ae04-99212b939d4912012-07-24
65862-070-50ML - Milliliter65862-0704ce48926-2b4e-4d8e-aab9-aefd015f244f12012-07-24
65862-070-75ML - Milliliter65862-070c190b0ae-ec45-48ab-b17d-cbcf55631cee12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYAMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]6
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-070AMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]15Current NDC, Legacy NDC, 3 package rows20240612_3cacd754-73f4-496e-a529-9ca39fa6692d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313850amoxicillin 200 MG in 5 mL Oral SuspensionPSN3cacd754-73f4-496e-a529-9ca39fa6692d15
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN3cacd754-73f4-496e-a529-9ca39fa6692d15
313850amoxicillin 40 MG/ML Oral SuspensionSCD3cacd754-73f4-496e-a529-9ca39fa6692d15
308189amoxicillin 80 MG/ML Oral SuspensionSCD3cacd754-73f4-496e-a529-9ca39fa6692d15
313850amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral SuspensionSY3cacd754-73f4-496e-a529-9ca39fa6692d15
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY3cacd754-73f4-496e-a529-9ca39fa6692d15
313850amoxicillin 200 MG per 5 ML Oral SuspensionSY3cacd754-73f4-496e-a529-9ca39fa6692d15
313850amoxicillin 200 MG in 5 mL Oral SuspensionPSN573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
313850amoxicillin 40 MG/ML Oral SuspensionSCD573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
308189amoxicillin 80 MG/ML Oral SuspensionSCD573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
313850amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral SuspensionSY573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
313850amoxicillin 200 MG per 5 ML Oral SuspensionSY573fcf4a-2b87-45d9-ac73-e1dec4fbc28b4
313850amoxicillin 200 MG in 5 mL Oral SuspensionPSNa91d9ff1-57dc-4569-9d0d-3d1b6ded97732
313850amoxicillin 200 MG in 5 mL Oral SuspensionPSN4d15e38c-2025-4570-839f-dfd4febd6ce32
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN4d15e38c-2025-4570-839f-dfd4febd6ce32
313850amoxicillin 40 MG/ML Oral SuspensionSCD4d15e38c-2025-4570-839f-dfd4febd6ce32
313850amoxicillin 40 MG/ML Oral SuspensionSCDa91d9ff1-57dc-4569-9d0d-3d1b6ded97732
308189amoxicillin 80 MG/ML Oral SuspensionSCD4d15e38c-2025-4570-839f-dfd4febd6ce32
313850amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral SuspensionSY4d15e38c-2025-4570-839f-dfd4febd6ce32
313850amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral SuspensionSYa91d9ff1-57dc-4569-9d0d-3d1b6ded97732
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY4d15e38c-2025-4570-839f-dfd4febd6ce32
313850amoxicillin 200 MG per 5 ML Oral SuspensionSY4d15e38c-2025-4570-839f-dfd4febd6ce32
313850amoxicillin 200 MG per 5 ML Oral SuspensionSYa91d9ff1-57dc-4569-9d0d-3d1b6ded97732
313850amoxicillin 200 MG in 5 mL Oral SuspensionPSNd5eba477-e255-4d97-9e16-30543c2986801
313850amoxicillin 40 MG/ML Oral SuspensionSCDd5eba477-e255-4d97-9e16-30543c2986801
313850amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral SuspensionSYd5eba477-e255-4d97-9e16-30543c2986801
313850amoxicillin 200 MG per 5 ML Oral SuspensionSYd5eba477-e255-4d97-9e16-30543c2986801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-070-0165862007001100 mL in 1 BOTTLE (65862-070-01) 100 ml2006-12-280000-00-00NoNoCurrent
65862-070-506586200705050 mL in 1 BOTTLE (65862-070-50) 50 ml2006-12-280000-00-00NoNoCurrent
65862-070-756586200707575 mL in 1 BOTTLE (65862-070-75) 75 ml2006-12-280000-00-00NoNoCurrent