NDC Code(s) : 52817-380-10, 52817-381-10
Packager : TruPharma LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NaproxenNaproxen TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-380
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN(UNII: 57Y76R9ATQ)
(NAPROXEN - UNII:57Y76R9ATQ) 		NAPROXEN375 mg
Inactive Ingredients
Ingredient Name Strength
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)
Product Characteristics
Color white Score no score
Shape OVAL (Oval) Size 14 mm
Flavor Imprint Code T54
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52817-380-10100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product08/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216908 07/27/2023
NaproxenNaproxen TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-381
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN(UNII: 57Y76R9ATQ)
(NAPROXEN - UNII:57Y76R9ATQ) 		NAPROXEN500 mg
Inactive Ingredients
Ingredient Name Strength
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)
Product Characteristics
Color white (enteric coated) Score no score
Shape OVAL (Biconvex) Size 16 mm
Flavor Imprint Code T55
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52817-381-10100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product08/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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)

PRINCIPAL DISPLAY PANEL

375 mg tab

NDC 52817-380-10

Rx Only

Naproxen

Delayed-Release Tablets, USP

375 mg

PHARMACIST: Dispense the Medication Guide provided separately to each patient

100 Tablets

Medication Guide availbale at website www.trupharma.com

TAMPER-EVIDENT CONTAINER.

DO NOT USE IF SEAL IS BROKEN
PACKAGE IS CHILD-RESISTANT

Dispense in light-resistant containers

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]

USUAL DOSAGE: See package insert

Keep out of reach of children

Manufactured By:

Tulex Pharmaceuticals Inc.

Cranbury, NJ 08512

Distributed By:

TruPharma LLC,

Tampa, FL33609

Code No. LA3801000300 Rev 06/2023

375 mg tab

NDC 52817-381-10 Rx Only

Naproxen

Delayed-Release Tablets, USP

500 mg

PHARMACIST: Dispense the Medication Guide provided separately to each patient

100 Tablets

Medication Guide availbale at website www.trupharma.com

TAMPER-EVIDENT CONTAINER.

DO NOT USE IF SEAL IS BROKEN
PACKAGE IS CHILD-RESISTANT

Dispense in light-resistant containers

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]

USUAL DOSAGE: See package insert

Keep out of reach of children

Manufactured By:

Tulex Pharmaceuticals Inc.

Cranbury, NJ 08512

Distributed By:

TruPharma LLC

Tampa, FL 33609

Code No. LA3811000300 Rev 06/2023