48102-111 : Amoxicillin Extended-release 775 mg Oral Tablet, Film Coated, Extended Release

NDC:	48102-111
Labeler:	Fera Pharmaceuticals, LLC
Product Type:	Human Prescription Drug
Drug Name:	Amoxicillin Extended-release
Dosage Form:	Oral Tablet, Film Coated, Extended Release
Application #:	NDA050813
Rev. Date:	Jul 28, 2014

Appearance:

Markings:	MB;111
Shapes:	Oval
Colors:	Blue
Size (mm):	22
Segments: *	1
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

• 48102-111-30: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (48102‑111‑30)

Active Ingredients:

• Amoxicillin

Inactive Ingredients:

• Crospovidone
• Fd&c Blue No. 2
• Hypromelloses
• Hypromellose Acetate Succinate 16070722 (3 Mm2/S)
• Ferric Oxide Red
• Magnesium Stearate
• Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)
• Cellulose, Microcrystalline
• Polyethylene Glycol 400
• Polyoxyl 35 Castor Oil
• Povidone
• Shellac
• Colloidal Silicon Dioxide
• Sodium Lauryl Sulfate
• Talc
• Titanium Dioxide
• Triethyl Citrate

Pharmaceutical Classes:

• Penicillin-class Antibacterial [EPC]
• Penicillins [Chemical/Ingredient]

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