70518-1172 : Naproxen Sodium 550 mg Oral Tablet, Film Coated

NDC:	70518-1172
Labeler:	Remedyrepack Inc.
Product Type:	Human Prescription Drug
Drug Name:	Naproxen Sodium
Dosage Form:	Oral Tablet, Film Coated
Application #:	ANDA200629
Rev. Date:	May 14, 2018

Appearance:

Markings:	T;22
Shapes:	Capsule
Colors:	Blue
Size (mm):	19
Segments: *	2
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

• 70518-1172-0: 30 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (70518‑1172‑0)

Active Ingredients:

• Naproxen Sodium

Inactive Ingredients:

• Silicon Dioxide
• Fd&c Blue No. 2
• Hypromellose 2910 (6 Mpa.s)
• Magnesium Stearate
• Microcrystalline Cellulose
• Polyethylene Glycol 8000
• Povidone K30
• Talc
• Titanium Dioxide /

Pharmaceutical Classes:

• Cyclooxygenase Inhibitors [MoA]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]
• Nonsteroidal Anti-inflammatory Drug [EPC]

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