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Naproxen

These highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976

Approved
Approval ID

004bb832-29d5-add0-e063-6394a90a90f4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 27, 2023

Manufacturers
FDA

TruPharma LLC

DUNS: 078533947

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Naproxen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code52817-381
Application NumberANDA216908
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen
Product Specifications
Route of AdministrationORAL
Effective DateJuly 27, 2023
FDA Product Classification

INGREDIENTS (11)

TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
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 Code52817-380
Application NumberANDA216908
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen
Product Specifications
Route of AdministrationORAL
Effective DateJuly 27, 2023
FDA Product Classification

INGREDIENTS (12)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
NAPROXENActive
Quantity: 375 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT

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Naproxen - FDA Drug Approval Details