MedPath

AMOXIL

AMOXICILLIN ORAL SUSP 250mg/5mL 150mL

Approved
Approval ID

330a6a2e-1224-557c-e054-00144ff8d46c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 12, 2023

Manufacturers
FDA

Direct_Rx

DUNS: 079254320

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

AMOXICILLIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code61919-716
Application NumberANDA065322
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMOXICILLIN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2023
FDA Product Classification

INGREDIENTS (7)

SUCROSEInactive
Code: C151H8M554
Classification: IACT
AMOXICILLINActive
Quantity: 250 mg in 5 mL
Code: 804826J2HU
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT

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AMOXIL - FDA Drug Approval Details