Naprelan (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

NDC 59630-375-10
NAPRELAN
(naproxen sodium)
CONTROLLED-RELEASED TABLETS
350 mg
Rx only 100 TabletsSHIONOGI INC

NDC 59630-375-10 NAPRELAN (naproxen sodium) CONTROLLED-RELEASED TABLETS 350 mg Rx only 100 Tablets SHIONOGI INC
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 59630-850-75
NAPRELAN
(naproxen sodium)
CONTROLLED-RELEASED TABLETS
500 mg
Rx only 75 TabletsSHIONOGI INC

NDC 59630-850-75 NAPRELAN (naproxen sodium) CONTROLLED-RELEASED TABLETS 500 mg Rx only 75 Tablets SHIONOGI INC
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 59630-777-03
NAPRELAN
(naproxen sodium)
CONTROLLED-RELEASED TABLETS
750 mg
Rx only 30 TabletsSHIONOGI INC

NDC 59630-777-03 NAPRELAN (naproxen sodium) CONTROLLED-RELEASED TABLETS 750 mg Rx only 30 Tablets SHIONOGI INC
(click image for full-size original)
NAPRELAN naproxen sodium tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59630-375
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN 375 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIO METHACRYLATE COPOLYMER TYPE A
AMMONIO METHACRYLATE COPOLYMER TYPE B
CITRIC ACID MONOHYDRATE
CROSPOVIDONE
MAGNESIUM STEARATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
CELLULOSE, MICROCRYSTALLINE
POVIDONES
TALC
HYPROMELLOSES
POLYETHYLENE GLYCOLS
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code N;375
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59630-375-10 100 TABLET, FILM COATED, EXTENDED RELEASE (100 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020353 04/01/1996
NAPRELAN naproxen sodium tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59630-850
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN 500 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIO METHACRYLATE COPOLYMER TYPE A
AMMONIO METHACRYLATE COPOLYMER TYPE B
CITRIC ACID MONOHYDRATE
CROSPOVIDONE
MAGNESIUM STEARATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
CELLULOSE, MICROCRYSTALLINE
POVIDONES
TALC
HYPROMELLOSES
POLYETHYLENE GLYCOLS
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code N;500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59630-850-75 75 TABLET, FILM COATED, EXTENDED RELEASE (75 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020353 04/01/1996
NAPRELAN naproxen sodium tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59630-777
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN 750 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIO METHACRYLATE COPOLYMER TYPE A
AMMONIO METHACRYLATE COPOLYMER TYPE B
CITRIC ACID MONOHYDRATE
CROSPOVIDONE
MAGNESIUM STEARATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
CELLULOSE, MICROCRYSTALLINE
POVIDONES
TALC
HYPROMELLOSES
POLYETHYLENE GLYCOLS
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code N;750
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59630-777-03 30 TABLET, FILM COATED, EXTENDED RELEASE (30 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020353 04/01/1996
Labeler — Shionogi Inc. (949127786)
Establishment
Name Address ID/FEI Operations
ALKERMES PHARMA IRELAND LIMITED 896838492 MANUFACTURE (59630-777), MANUFACTURE (59630-850), MANUFACTURE (59630-375)

Revised: 08/2013 Shionogi Inc.

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