10544-614 : Naproxen 550 mg Oral Tablet, Film Coated

NDC:	10544-614
Labeler:	Blenheim Pharmacal, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Naproxen
Dosage Form:	Oral Tablet, Film Coated
Application #:	ANDA074480
Rev. Date:	May 17, 2010

Appearance:

Markings:	H;2
Shapes:	Capsule
Colors:	White
Size (mm):	7
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:

• 10544-614-20: 20 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (10544‑614‑20)

Active Ingredients:

• Naproxen Sodium

Inactive Ingredients:

• Silicon Dioxide
• Croscarmellose Sodium
• Lactose Monohydrate
• Magnesium Stearate
• Cellulose, Microcrystalline
• Povidone K30
• Sodium Lauryl Sulfate
• Hypromelloses
• Talc
• Titanium Dioxide

Pharmaceutical Classes:

• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]

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