NDC Code 52817-381-10 - Naproxen

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

NaproxenNaproxen TABLET, DELAYED RELEASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NAPROXEN(UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN	375 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52817-380-10	100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	08/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA216908	07/27/2023

NaproxenNaproxen TABLET, DELAYED RELEASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NAPROXEN(UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN	500 mg

Ingredient Name	Strength
Inactive Ingredients
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52817-381-10	100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	08/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA216908	07/27/2023

LABELER - TruPharma LLC(078533947)

REGISTRANT - Tulex Pharmaceuticals Inc.(080119240)

Establishment
Name	Address	ID/FEI	Business Operations
Tulex Pharmaceuticals Inc.		080119240	analysis(52817-380, 52817-381), label(52817-380, 52817-381), manufacture(52817-380, 52817-381), pack(52817-380, 52817-381)

NDC 52817-381-10
API & Excipient Details