Naprelan
Naprelan
Approved
Approval ID
15ab6690-53bf-4669-950f-35db4dba8fac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 2013
Manufacturers
FDA
Shionogi Inc.
DUNS: 949127786
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Naproxen Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59630-777
Application NumberNDA020353
Product Classification
M
Marketing Category
C73594
G
Generic Name
Naproxen Sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2013
FDA Product Classification
INGREDIENTS (13)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
NAPROXEN SODIUMActive
Quantity: 750 mg in 1 1
Code: 9TN87S3A3C
Classification: ACTIM
AMMONIO METHACRYLATE COPOLYMER TYPE AInactive
Code: 8GQS4E66YY
Classification: IACT
AMMONIO METHACRYLATE COPOLYMER TYPE BInactive
Code: 161H3B14U2
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
Naproxen Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59630-375
Application NumberNDA020353
Product Classification
M
Marketing Category
C73594
G
Generic Name
Naproxen Sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2013
FDA Product Classification
INGREDIENTS (13)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
NAPROXEN SODIUMActive
Quantity: 375 mg in 1 1
Code: 9TN87S3A3C
Classification: ACTIM
AMMONIO METHACRYLATE COPOLYMER TYPE AInactive
Code: 8GQS4E66YY
Classification: IACT
AMMONIO METHACRYLATE COPOLYMER TYPE BInactive
Code: 161H3B14U2
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Naproxen Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59630-850
Application NumberNDA020353
Product Classification
M
Marketing Category
C73594
G
Generic Name
Naproxen Sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2013
FDA Product Classification
INGREDIENTS (13)
NAPROXEN SODIUMActive
Quantity: 500 mg in 1 1
Code: 9TN87S3A3C
Classification: ACTIM
AMMONIO METHACRYLATE COPOLYMER TYPE AInactive
Code: 8GQS4E66YY
Classification: IACT
AMMONIO METHACRYLATE COPOLYMER TYPE BInactive
Code: 161H3B14U2
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT