55315-435 : Famotidine 20 mg Oral Tablet, Film Coated

NDC:	55315-435
Labeler:	Fred's, Inc.
Product Type:	Human OTC Drug
Drug Name:	Famotidine
Dosage Form:	Oral Tablet, Film Coated
Application #:	ANDA206531
Rev. Date:	Apr 26, 2016

Appearance:

Markings:	CC;59
Shapes:	Round
Colors:	Yellow
Size (mm):	5
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:

• 55315-435-53: 1 BOTTLE IN 1 CARTON (55315‑435‑53) > 25 TABLET, FILM COATED IN 1 BOTTLE

Active Ingredients:

• Famotidine

Inactive Ingredients:

• Carnauba Wax
• Starch, Corn
• Hydroxypropyl Cellulose (1600000 Wamw)
• Hypromellose 2910 (5 Mpa.s)
• Magnesium Stearate
• Microcrystalline Cellulose
• Ferric Oxide Red
• Sodium Starch Glycolate Type a Corn
• Talc
• Titanium Dioxide
• Ferric Oxide Yellow /

Pharmaceutical Classes:

• Histamine H2 Receptor Antagonists [MoA]
• Histamine-2 Receptor Antagonist [EPC]

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