NAPROXEN SODIUM TABLET [DIRECT RX]

NAPROXEN SODIUM TABLET [DIRECT RX]
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NDC	61919-470-50
Set ID	2d78bd54-2eda-37a7-e054-00144ff88e88
Category	HUMAN PRESCRIPTION DRUG LABEL
Packager	DIRECT RX
Generic Name
Product Class
Product Number
Application Number	ANDA074661

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Active ingredient (in each tablet)
Purpose
Uses
Warnings
Directions
Other information
Inactive ingredients
Principal Display Panel

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM
naproxen sodium tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:61919-470(NDC:57896-951)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN SODIUM	220 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	144
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61919-470-50	50 in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090545	03/12/2018

Labeler - DIRECT RX (079254320)

Name	Address	ID/FEI	Business Operations
Establishment
DIRECT RX		079254320	repack(61919-470)

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