Label: NAPROXEN SODIUM tablet, film coated
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NDC Code(s):
62207-761-21,
62207-761-22,
62207-761-24,
62207-761-28, view more62207-761-31, 62207-761-32, 62207-761-33, 62207-761-34, 62207-761-36, 62207-762-21, 62207-762-22, 62207-762-24, 62207-762-28, 62207-762-31, 62207-762-32, 62207-762-33, 62207-762-34, 62207-762-36
- Packager: Granules India Limited
- Category: BULK INGREDIENT
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated January 9, 2024
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SPL UNCLASSIFIED SECTION
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
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INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium tablet, film coatedProduct 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 coatedProduct 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)
