FDA.reportPublic FDA data

Amoxicillin

Product NDC
57237-033
11-digit product format
572370033
Labeler code
57237
Product ID
57237-033_62bfc65c-04fe-43b5-b659-d37067b280c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA065334
Marketing category
ANDA
Marketing start
2006-12-28
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
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
57237-033-01Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION10010
57237-033-50Amoxicillin50 mL in 1 BOTTLEPOWDER, FOR SUSPENSION5010
57237-033-75Amoxicillin75 mL in 1 BOTTLEPOWDER, FOR SUSPENSION7510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-033-01ML - Milliliter57237-03398cb899b-9b1c-4c4f-ac39-e091b8be5d4d12014-04-03
57237-033-50ML - Milliliter57237-0332ac184b7-093f-4244-aedc-94c5139f7db112015-01-05
57237-033-75ML - Milliliter57237-03377fe30a1-70cd-434a-883a-637e938f08c012014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN POWDER, FOR SUSPENSION [CITRON PHARMA LLC]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [CITRON PHARMA LLC]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMOXICILLIN POWDER, FOR SUSPENSION [CITRON PHARMA LLC]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYAMOXICILLIN POWDER, FOR SUSPENSION [CITRON PHARMA LLC]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [CITRON PHARMA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAMOXICILLIN POWDER, FOR SUSPENSION [CITRON PHARMA LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [CITRON PHARMA LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [CITRON PHARMA LLC]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [CITRON PHARMA LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-033AMOXICILLIN POWDER, FOR SUSPENSION [RISING PHARMA HOLDINGS, INC.]10Current NDC, Legacy NDC, 3 package rows20240814_554239db-69fe-405a-910a-d9f9e3f8b6ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313850amoxicillin 200 MG in 5 mL Oral SuspensionPSN554239db-69fe-405a-910a-d9f9e3f8b6ed10
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSN554239db-69fe-405a-910a-d9f9e3f8b6ed10
313850amoxicillin 40 MG/ML Oral SuspensionSCD554239db-69fe-405a-910a-d9f9e3f8b6ed10
308189amoxicillin 80 MG/ML Oral SuspensionSCD554239db-69fe-405a-910a-d9f9e3f8b6ed10
313850amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral SuspensionSY554239db-69fe-405a-910a-d9f9e3f8b6ed10
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSY554239db-69fe-405a-910a-d9f9e3f8b6ed10
313850amoxicillin 200 MG per 5 ML Oral SuspensionSY554239db-69fe-405a-910a-d9f9e3f8b6ed10
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSNe40f3e20-facf-46f4-89c7-3593bc27d0fc4
308189amoxicillin 80 MG/ML Oral SuspensionSCDe40f3e20-facf-46f4-89c7-3593bc27d0fc4
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSYe40f3e20-facf-46f4-89c7-3593bc27d0fc4
308189amoxicillin 400 MG in 5 mL Oral SuspensionPSNcedde8f5-aadd-53de-e053-2995a90aab163
308189amoxicillin 80 MG/ML Oral SuspensionSCDcedde8f5-aadd-53de-e053-2995a90aab163
308189amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral SuspensionSYcedde8f5-aadd-53de-e053-2995a90aab163

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-033-0157237003301100 mL in 1 BOTTLE (57237-033-01) 100 ml2006-12-280000-00-00NoNoCurrent
57237-033-505723700335050 mL in 1 BOTTLE (57237-033-50) 50 ml2006-12-280000-00-00NoNoCurrent
57237-033-755723700337575 mL in 1 BOTTLE (57237-033-75) 75 ml2006-12-280000-00-00NoNoCurrent