NAPROXEN SODIUM- naproxen sodium tablet, film coated 
Granules India Limited

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NAPROXEN SODIUM TABLETS USP 220 MG (TABLET/CAPLET)

Each film coated tablet/caplet contains
Naproxen Sodium USP 220 mg (naproxen 200 mg)

BOX

Batch No.:XXXNo. of Units50,000 (5 x 10,000)
Mfg. Dt.:XXXGross Wt.:XXX kg
Exp. Dt.:XXXTare Wt.:XXX kg
NDC No.XXXNet Wt.:XXX kg
Mfg. Lic. No.:37/RR/AP/2003/F/RBox No.:XXX
Storage:Store at controlled room temperature [store at 20° – 25°C (68° – 77°F); Avoid humidity and excessive heat above 40°C (104°F).
Caution:For repacking only.

POUCH

Batch No.:XXXNo. of Units10,000
Mfg. Dt.:XXX
Exp. Dt.:XXX
NDC No.XXX
Mfg. Lic. No.:37/RR/AP/2003/F/R
Storage:Store at controlled room temperature [store at 20° – 25°C (68° – 77°F); Avoid humidity and excessive heat above 40°C (104°F).
Caution:For repacking only.

Country of Origin: INDIA

Product code: XXXXXX

Manufactured in India by:
Granules India Limited
Plot No. 160/A, 161/E, Gagillapur Village
Qutbullapur Mandal, Ranga Reddy Dt – 500 043, AP.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

761-32

761-36

762-32

762-36

NAPROXEN SODIUM 
naproxen sodium tablet, film coated
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:62207-761
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
Product Characteristics
Colorblue (light blue) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code 220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-761-215000 in 1 BOX03/12/2014
2NDC:62207-761-2225000 in 1 BOX03/12/2014
3NDC:62207-761-2448000 in 1 BOX03/12/2014
4NDC:62207-761-2850000 in 1 BOX03/12/2014
5NDC:62207-761-315000 in 1 POUCH03/12/2014
6NDC:62207-761-3210000 in 1 POUCH03/12/2014
7NDC:62207-761-3325000 in 1 POUCH03/12/2014
8NDC:62207-761-3415000 in 1 POUCH03/12/2014
9NDC:62207-761-3650000 in 1 POUCH03/12/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only03/12/2014
NAPROXEN SODIUM 
naproxen sodium tablet, film coated
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:62207-762
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
Product Characteristics
Colorblue (light blue) Scoreno score
ShapeOVAL (caplet-shaped) Size12mm
FlavorImprint Code 220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-762-215000 in 1 BOX03/12/2014
2NDC:62207-762-2225000 in 1 BOX03/12/2014
3NDC:62207-762-2448000 in 1 BOX03/12/2014
4NDC:62207-762-2850000 in 1 BOX03/12/2014
5NDC:62207-762-315000 in 1 POUCH03/12/2014
6NDC:62207-762-3210000 in 1 POUCH03/12/2014
7NDC:62207-762-3325000 in 1 POUCH03/12/2014
8NDC:62207-762-3415000 in 1 POUCH03/12/2014
9NDC:62207-762-3650000 in 1 POUCH03/12/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only03/12/2014
Labeler - Granules India Limited (915000087)
Registrant - Granules India Limited (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited918609236manufacture(62207-761, 62207-762) , analysis(62207-761, 62207-762) , pack(62207-761, 62207-762)

Revised: 1/2024
Document Id: 0e81a10f-9347-d142-e063-6394a90a28d0
Set id: 506161f7-3bce-4c4d-8c05-8f3b0d5f88df
Version: 8
Effective Time: 20240109
 
Granules India Limited