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Naprosyn

These highlights do not include all the information needed to use NAPROSYN Tablets, EC-NAPROSYN and ANAPROX DS safely and effectively. See full prescribing information for NAPROSYN, EC-NAPROSYN and ANAPROX DS. NAPROSYN (naproxen) tablets, EC-NAPROSYN (naproxen delayed-release tablets), ANAPROX DS (naproxen sodium tablets), for oral use Initial U.S. Approval: 1976

Approved
Approval ID

8bff5df5-d856-4237-b6a8-ae445b454844

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 30, 2021

Manufacturers
FDA

Canton Laboratories

DUNS: 079589614

Products 4

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 Code69437-203
Application NumberNDA018164
Product Classification
M
Marketing Category
C73594
G
Generic Name
naproxen sodium
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2019
FDA Product Classification

INGREDIENTS (5)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
NAPROXEN SODIUMActive
Quantity: 550 mg in 1 1
Code: 9TN87S3A3C
Classification: ACTIB

naproxen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69437-316
Application NumberNDA017581
Product Classification
M
Marketing Category
C73594
G
Generic Name
naproxen
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2019
FDA Product Classification

INGREDIENTS (5)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
NAPROXENActive
Quantity: 500 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT

naproxen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69437-416
Application NumberNDA020067
Product Classification
M
Marketing Category
C73594
G
Generic Name
naproxen
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2019
FDA Product Classification

INGREDIENTS (9)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
NAPROXENActive
Quantity: 500 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

naproxen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69437-415
Application NumberNDA020067
Product Classification
M
Marketing Category
C73594
G
Generic Name
naproxen
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2019
FDA Product Classification

INGREDIENTS (9)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
NAPROXENActive
Quantity: 375 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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