NAPROXEN SODIUM TABLETS USP 220 MG (TABLET/CAPLET)

Naproxen Sodium by

Drug Labeling and Warnings

Naproxen Sodium by is a Other medication manufactured, distributed, or labeled by Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.:	XXX	No. of Units	50,000 (5 x 10,000)
Mfg. Dt.:	XXX	Gross Wt.:	XXX kg
Exp. Dt.:	XXX	Tare Wt.:	XXX kg
NDC No.	XXX	Net Wt.:	XXX kg
Mfg. Lic. No.:	37/RR/AP/2003/F/R	Box 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.:	XXX	No. of Units	10,000
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

NAPROXEN SODIUM 
naproxen sodium tablet, film coated

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 62207-761
Route of Administration	NOT APPLICABLE

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

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue (light blue)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	220
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-761-21	5000 in 1 BOX	03/12/2014
2	NDC: 62207-761-22	25000 in 1 BOX	03/12/2014
3	NDC: 62207-761-24	48000 in 1 BOX	03/12/2014
4	NDC: 62207-761-28	50000 in 1 BOX	03/12/2014
5	NDC: 62207-761-31	5000 in 1 POUCH	03/12/2014
6	NDC: 62207-761-32	10000 in 1 POUCH	03/12/2014
7	NDC: 62207-761-33	25000 in 1 POUCH	03/12/2014
8	NDC: 62207-761-34	15000 in 1 POUCH	03/12/2014
9	NDC: 62207-761-36	50000 in 1 POUCH	03/12/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		03/12/2014

NAPROXEN SODIUM 
naproxen sodium tablet, film coated

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 62207-762
Route of Administration	NOT APPLICABLE

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

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue (light blue)	Score	no score
Shape	OVAL (caplet-shaped)	Size	12mm
Flavor		Imprint Code	220
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-762-21	5000 in 1 BOX	03/12/2014
2	NDC: 62207-762-22	25000 in 1 BOX	03/12/2014
3	NDC: 62207-762-24	48000 in 1 BOX	03/12/2014
4	NDC: 62207-762-28	50000 in 1 BOX	03/12/2014
5	NDC: 62207-762-31	5000 in 1 POUCH	03/12/2014
6	NDC: 62207-762-32	10000 in 1 POUCH	03/12/2014
7	NDC: 62207-762-33	25000 in 1 POUCH	03/12/2014
8	NDC: 62207-762-34	15000 in 1 POUCH	03/12/2014
9	NDC: 62207-762-36	50000 in 1 POUCH	03/12/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		03/12/2014

Labeler - Granules India Limited (915000087)

Registrant - Granules India Limited (915000087)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	manufacture(62207-761, 62207-762) , analysis(62207-761, 62207-762) , pack(62207-761, 62207-762)

Revised: 1/2024

Document Id: 0e81a10f-9347-d142-e063-6394a90a28d0

53409-9

Set id: 506161f7-3bce-4c4d-8c05-8f3b0d5f88df

Version: 8

Effective Time: 20240109