FDA.reportPublic FDA data

Amoxicillin

Product NDC
33261-766
11-digit product format
332610766
Labeler code
33261
Product ID
33261-766_12a87643-479a-4a6c-b307-646c58aa89f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA065334
Marketing category
ANDA
Marketing start
2006-12-28
Marketing end
0000-00-00
Substance
AMOXICILLIN
Active strength
200 mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-766-012020-01-31C16284748780-19d75b9d0-4f7e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use amoxicillin for oral suspension safely and effectively. See full prescribing information for amoxicillin for oral suspension, USP. Amoxicillin for Oral Suspension, USP Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-766-01Amoxicillin100 mL in 1 BOTTLE, PLASTICPOWDER, FOR SUSPENSION1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-766-01ML - Milliliter33261-76613ec8e6c-6f52-4e3f-b06f-a569e38c78c412015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-766AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 1 package rows20140327_4d15e38c-2025-4570-839f-dfd4febd6ce3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
33261-766-0133261076601100 mL in 1 BOTTLE, PLASTIC100 mlHistorical