Amoxicillin
Amoxicillin Capsules USP, 250 mg and Amoxicillin Capsules USP, 500 mg
Approved
Approval ID
3afc3097-a757-49a0-aaec-85ac267aabb1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2010
Manufacturers
FDA
Blenheim Pharmacal, Inc.
DUNS: 171434587
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 Code10544-619
Application NumberANDA065291
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2010
FDA Product Classification
INGREDIENTS (6)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
AMOXICILLINActive
Quantity: 500 mg in 1 1
Code: 804826J2HU
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT