Naproxen (Page 9 of 9)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg (100 Tablets Bottle)

NDC 65862-522-01
Rx only
Naproxen Tablets USP
500 mg
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY
AUROBINDO 100 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 500 mg (100 Tablets Bottle)
(click image for full-size original)

NAPROXEN naproxen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-520
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN (NAPROXEN) NAPROXEN 250 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color YELLOW (Mottled Yellow) Score 2 pieces
Shape ROUND (Biconvex, Beveled Edged) Size 11mm
Flavor Imprint Code T;18
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-520-01 100 TABLET in 1 BOTTLE None
2 NDC:65862-520-05 500 TABLET in 1 BOTTLE None
3 NDC:65862-520-99 1000 TABLET in 1 BOTTLE None
4 NDC:65862-520-10 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (65862-520-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200429 11/08/2011
NAPROXEN naproxen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-521
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN (NAPROXEN) NAPROXEN 375 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color YELLOW (Mottled Yellow) Score no score
Shape OVAL (Biconvex) Size 16mm
Flavor Imprint Code T;19
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-521-01 100 TABLET in 1 BOTTLE None
2 NDC:65862-521-05 500 TABLET in 1 BOTTLE None
3 NDC:65862-521-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200429 11/08/2011
NAPROXEN naproxen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-522
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN (NAPROXEN) NAPROXEN 500 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color YELLOW (Mottled Yellow) Score 2 pieces
Shape CAPSULE (Biconvex) Size 19mm
Flavor Imprint Code T;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-522-01 100 TABLET in 1 BOTTLE None
2 NDC:65862-522-05 500 TABLET in 1 BOTTLE None
3 NDC:65862-522-26 2500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200429 11/08/2011
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-520), ANALYSIS (65862-521), ANALYSIS (65862-522), MANUFACTURE (65862-520), MANUFACTURE (65862-521), MANUFACTURE (65862-522)

Revised: 03/2023 Aurobindo Pharma Limited

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

https://medlibrary.org/lib/rx/meds/naproxen-58/page/9/

Clinical Trials

MedLibrary.org

Medication Sections

RSS Feeds

About

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2023. All Rights Reserved.