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Amoxicillin

Amoxicillin Capsules, USP

Approved
Approval ID

6136dcbf-9bde-4b5b-82b3-d7cb8bdb817b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 1, 2011

Manufacturers
FDA

RedPharm Drug Inc.

DUNS: 008039641

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 Code67296-0616
Application NumberANDA065271
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2011
FDA Product Classification

INGREDIENTS (9)

AMOXICILLINActive
Quantity: 500 mg in 1 1
Code: 804826J2HU
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT

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Amoxicillin - FDA Drug Approval Details