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Amoxicillin

These highlights do not include all the information needed to use AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES, safely and effectively. See full prescribing information for AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES. AMOXICILLIN tablets, for oral use AMOXICILLIN for oral suspension, AMOXICILLIN tablets (chewable), for oral use AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974

Approved
Approval ID

63b395ca-f0ea-4429-b8aa-18f495596e4d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 5, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 3

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 Code50090-0455
Application NumberANDA064013
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateJune 7, 2023
FDA Product Classification

INGREDIENTS (7)

AMOXICILLINActive
Quantity: 250 mg in 1 1
Code: 804826J2HU
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Amoxicillin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-3005
Application NumberANDA061931
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateJune 7, 2023
FDA Product Classification

INGREDIENTS (7)

AMOXICILLINActive
Quantity: 125 mg in 5 mL
Code: 804826J2HU
Classification: ACTIM
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

Amoxicillin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-1814
Application NumberANDA061931
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateJune 7, 2023
FDA Product Classification

INGREDIENTS (7)

FD&C RED NO. 40Inactive
Code: WZB9127XOA
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
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

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Amoxicillin - FDA Drug Approval Details